Allergic ConjunctivitisPhase 4NCT05314621
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis
A Phase 4 study testing olopatadine hydrochloride ophthalmic solution 0.7%), Fluticasone Propionate and Tears Naturale in people with Allergic Conjunctivitis, run by Andover Research Eye Institute at 1 site in United States.
Trial summary
This is a single-center, randomized, double-masked, parallel study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- olopatadine hydrochloride ophthalmic solution 0.7%), Fluticasone Propionate and Tears Naturale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to 24 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age at Visit 1 of either gender and any race;
- Provide written informed consent and sign the HIPAA form;
- Be willing and able to follow all instructions and attend all study visits;
- Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose;
- Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months;
- Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6);
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- Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 and during the study trial period;
- (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
- Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
- Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) within 10 (±2) minutes of instillation of the last titration of allergen at Visit 1;
- Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) for at least two out of the first three time points following the challenge at Visit 2.
Who cannot join
- Have known contraindications or sensitivities to the use of the investigational product or any of its components;
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye);
- Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months;
- Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
- Use any of the following disallowed medications during the period indicated prior to Visit 1 and during the study:
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- 7 Days
- systemic or ocular H1-antihistamine, H1-antihistamine/mast cell stabilizers, H1-antihistamine-vasoconstrictor drug combinations;
- decongestants;
- monoamine oxidase inhibitors
- all other topical ophthalmic preparations (including artificial tears)
- lid scrubs;
- topical prostaglandins or prostaglandin derivatives
- ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs, including baby aspirin (81 mg)) 14 Days
- inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers
- ritonavir or other potent cytochrome P450 3A4 inhibitors; 45 Days
- depo-corticosteroids; Note: Currently marketed over-the-counter anti-allergy eye drops (i.e. anti-histamine/vasoconstrictor combination products such as Visine®-A®) may be administered to subjects by trained study personnel at the end of Visits 1, 2 and 4b after all evaluations are completed.
- 7. Have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease [including arrhythmias] the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens;
- 8. Have received allergy immunotherapy within the last 2 years;
- 9. Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 1, 2, or 3 (defined as the presence of any itching or >1 [greater than 1] redness in any vessel bed);
- 10. Have a history of glaucoma;
- 11. Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
- 12. Have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;
- 13. Be a female who is currently pregnant, planning a pregnancy, or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis
This is a single-center, randomized, double-masked, parallel study.
Read the detailed description
At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1.
For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio:
- Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30)
- Tears Naturale® II and Flonase® Allergy Relief (n = 30)
At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing.
At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a.
- Conditions
- Allergic Conjunctivitis
- Being tested
- olopatadine hydrochloride ophthalmic solution 0.7%), Fluticasone Propionate, Tears Naturale, Saline nasal spray
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olopatadine hydrochloride ophthalmic solution 0.7%)Drug
Also called Pataday® Once Daily Relief Extra Strength
Pataday® Once Daily Relief Extra Strength (eyedrop)
Fluticasone PropionateDrug
Also called Flonase® Allergy Relief
Flonase® Allergy Relief (nasal spray)
Tears NaturaleDrug
Also called Tears Naturale® II
Tears Naturale® II (eye drop)
Saline nasal sprayDrug
Saline nasal spray (nasal spray)
| Study group | Role | What they receive |
|---|---|---|
| Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray | Active comparator | Pataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and saline nasal spray will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a. Receives: Drug: olopatadine hydrochloride ophthalmic solution 0.7%); Drug: Saline nasal spray |
| Tears Naturale® II and Flonase® Allergy Relief | Active comparator | Tears Naturale® II will be administered bilaterally and Flonase® Allergy Relief (fluticasone propionate) will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a. Receives: Drug: Fluticasone Propionate; Drug: Tears Naturale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching 3(±1) minutes post-CAC at Visit 3
Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 3(±1) minutes post-CAC on Day 1 (Visit 3)
Ocular itching 3(±1) minutes post-CAC at Visit 4b
Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Vi sit 4b.
Measured: 3(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Ocular itching 5(±1) minutes post-CAC at Visit 3
Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 5(±1) minutes post-CAC on Day 1 (Visit 3)
Ocular itching 5(±1) minutes post-CAC at Visit 4b
Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 5(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Ocular itching 7(±1) minutes post-CAC at Visit 3
Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Ocular itching 7(±1) minutes post-CAC at Visit 4b
Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary outcomes (60)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Conjunctival Redness
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Conjunctival Redness
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Conjunctival Redness
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ciliary Redness
Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ciliary Redness
Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ciliary Redness
Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Episcleral Redness
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Episcleral Redness
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Episcleral Redness
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Chemosis
Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Chemosis
Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Chemosis
Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Eyelid Swelling
Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Eyelid Swelling
Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Eyelid Swelling
Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Tearing
Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Tearing
Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Tearing
Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Rhinorrhea
Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Rhinorrhea
Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Rhinorrhea
Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Pruritis
Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Pruritis
Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Pruritis
Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis
Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis
Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis
Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Congestion
Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Congestion
Nasal congestion evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Congestion
Nasal congestion evaluated by the subject 0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 3.
Measured: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Conjunctival Redness
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Conjunctival Redness
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Conjunctival Redness
Conjunctival redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ciliary Redness
Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ciliary Redness
Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ciliary Redness
Ciliary redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Episcleral Redness
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Episcleral Redness
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Episcleral Redness
Episcleral redness evaluated by the investigator (0-4 on the Ocular Redness scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Chemosis
Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Chemosis
Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Chemosis
Chemosis evaluated by the investigator (0-4 on the Ocular Chemosis scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Eyelid Swelling
Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Eyelid Swelling
Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Eyelid Swelling
Eyelid swelling evaluated by the subject (0-3 on the Eyelid Swelling scale with 3 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Tearing
Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Tearing
Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Tearing
Tearing evaluated by the subject (0-4 on the Tearing scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Rhinorrhea
Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Rhinorrhea
Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Rhinorrhea
Rhinorrhea evaluated by the subject (0-4 on the Rhinorrhea scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Pruriti
Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Pruritis
Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Pruritis
Nasal pruritis evaluated by the subject (0-4 on the Nasal Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis
Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis
Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ear or Palate Pruritis
Ear or palate pruritis evaluated by the subject (0-4 on the Ear or Palate Pruritis scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Nasal Congestion
Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Nasal Congestion
Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Nasal Congestion
Nasal congestion pruritis evaluated by the subject (0-4 on the Nasal Congestion scale with 4 being the worst, not allowing half unit increments) at Visit 4b.
Measured: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start31 Dec 2021
- Primary completion24 Jul 2022
- Study completion24 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andover Research Eye Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314621
- Sponsor's protocol ID
- 21-960-0005
- Status last verified
- Sep 2022
- First submitted
- 17 Dec 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT05314621
- Acronym / sponsor ID
- 21-960-0005
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Andover Research Eye InstituteIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 24 Jul 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-masked, parallel study.
Detailed description
At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1.
For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio:
- Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30)
- Tears Naturale® II and Flonase® Allergy Relief (n = 30)
At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing.
At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray | Active comparator | Drug: olopatadine hydrochloride ophthalmic solution 0.7%), Drug: Saline nasal sprayPataday® Once Daily Relief Extra Strength (olopatadine hydrochloride ophthalmic solution 0.7%) will be administered bilaterally and saline nasal spray will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a. |
| Tears Naturale® II and Flonase® Allergy Relief | Active comparator | Drug: Fluticasone Propionate, Drug: Tears NaturaleTears Naturale® II will be administered bilaterally and Flonase® Allergy Relief (fluticasone propionate) will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be at least 18 years of age at Visit 1 of either gender and any race;
- Provide written informed consent and sign the HIPAA form;
- Be willing and able to follow all instructions and attend all study visits;
- Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose;
- Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months;
Key exclusion criteria (24 listed)
- Have known contraindications or sensitivities to the use of the investigational product or any of its components;
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, history of corneal transplantation or a diagnosis of dry eye);
- Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months;
- Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olopatadine hydrochloride ophthalmic solution 0.7%)Also: Pataday® Once Daily Relief Extra StrengthPataday® Once Daily Relief Extra Strength (eyedrop) | Drug | Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray |
| Fluticasone PropionateAlso: Flonase® Allergy ReliefFlonase® Allergy Relief (nasal spray) | Drug | Tears Naturale® II and Flonase® Allergy Relief |
| Tears NaturaleAlso: Tears Naturale® IITears Naturale® II (eye drop) | Drug | Tears Naturale® II and Flonase® Allergy Relief |
| Saline nasal spraySaline nasal spray (nasal spray) | Drug | Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray |
Primary outcome
Ocular itching 3(±1) minutes post-CAC at Visit 3
Time frame: 3(±1) minutes post-CAC on Day 1 (Visit 3)
Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.
Ocular itching 3(±1) minutes post-CAC at Visit 4b
Time frame: 3(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Ocular itching evaluated by the subject at 3(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Vi sit 4b.
Ocular itching 5(±1) minutes post-CAC at Visit 3
Time frame: 5(±1) minutes post-CAC on Day 1 (Visit 3)
Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.
Ocular itching 5(±1) minutes post-CAC at Visit 4b
Time frame: 5(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Ocular itching evaluated by the subject at 5(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.
Ocular itching 7(±1) minutes post-CAC at Visit 3
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 3.
Ocular itching 7(±1) minutes post-CAC at Visit 4b
Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Ocular itching evaluated by the subject at 7(±1) minutes post-CAC (0-4 on the Ocular Itching scale with 4 being the worst, allowing half unit increments) at Visit 4b.
60 secondary outcomes
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Conjunctival Redness
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Conjunctival Redness
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Conjunctival Redness
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ciliary Redness
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ciliary Redness
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ciliary Redness
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Episcleral Redness
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Episcleral Redness
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Episcleral Redness
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Chemosis
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Chemosis
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Chemosis
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Eyelid Swelling
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Eyelid Swelling
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Eyelid Swelling
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Tearing
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Tearing
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Tearing
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Rhinorrhea
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Rhinorrhea
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Rhinorrhea
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Pruritis
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Pruritis
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Pruritis
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Ear or Palate Pruritis
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 3; Nasal Congestion
Time frame: 7(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 3; Nasal Congestion
Time frame: 15(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 3; Nasal Congestion
Time frame: 20(±1) minutes post-CAC on Day 1 (Visit 3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Conjunctival Redness
Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Conjunctival Redness
Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Conjunctival Redness
Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Ciliary Redness
Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Ciliary Redness
Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Ciliary Redness
Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Episcleral Redness
Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 15(±1) minutes post-CAC at Visit 4b; Episcleral Redness
Time frame: 15(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 20(±1) minutes post-CAC at Visit 4b; Episcleral Redness
Time frame: 20(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Secondary Efficacy Measures 7(±1) minutes post-CAC at Visit 4b; Chemosis
Time frame: 7(±1) minutes post-CAC at Visit 4b (24 hours from Visit 4a; Day 15±3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olopatadine hydrochloride ophthalmic solution 0.7%), Fluticasone Propionate and Tears Naturale in people with Allergic Conjunctivitis, run by Andover Research Eye Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular itching 3(±1) minutes post-CAC at Visit 3 (time frame: 3(±1) minutes post-CAC on Day 1 (Visit 3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.