Allergic ConjunctivitisPhase 4NCT01534195
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
A Phase 4 study testing Prednisolone Sodium Phosphate Ophthalmic Solution 1% and Tears Naturale II Ophthalmic Solution in people with Allergic Conjunctivitis, run by ORA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: Ocular itching Conjunctival redness 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?
- Prednisolone Sodium Phosphate Ophthalmic Solution 1% and Tears Naturale II Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age \& either sex, any race
- Willing and able to follow all instructions
- Positive history of ocular allergies
- Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Who cannot join
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy or lactating
- Use of disallowed medications
- Have ocular infections, or ocular conditions that could affect study parameters
- Have moderate to severe dry eye
- Have used an investigational drug or device within 30 days of start of study
- Female that 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 Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,
Prednisolone, assessed by the following measures:
- Ocular itching
- Conjunctival redness
Read the detailed description
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.
- Prednisolone phosphate
- Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 19 days
Controls:
Artificial Tears (Tears Naturale® II)
- Conditions
- Allergic Conjunctivitis
- Being tested
- Prednisolone Sodium Phosphate Ophthalmic Solution 1%, Tears Naturale II Ophthalmic Solution
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone Sodium Phosphate Ophthalmic Solution 1%Drug
One drop in each eye, four times/day for 8 days.
Tears Naturale II Ophthalmic SolutionDrug
one drop in each eye, four times/ day (QID) for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Experimental | Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Receives: Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1% |
| Placebo | Placebo comparator | Tears Naturale II Ophthalmic Solution, 1% Receives: Drug: Tears Naturale II Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Change From Baseline to Day 11
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Measured: 5 minutes post-CAC
Secondary outcomes (3)
Conjunctival Redness Change From Baseline to Day 11
Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)
Measured: 7 Minutes post-CAC
Episcleral Redness Change From Baseline to Day 6
Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Measured: 7 minutes post-CAC
Ciliary Redness Change From Baseline to Day 6
Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Measured: 7 minutes post-CAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tarek Shazly, MD, Principal investigator, Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534195
- Sponsor's protocol ID
- 12-270-0001
- Status last verified
- Jul 2012
- First submitted
- 25 Jan 2012
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
- ClinicalTrials.gov ID
- NCT01534195
- Acronym / sponsor ID
- 12-270-0001
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Posted 15 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,
Prednisolone, assessed by the following measures:
- Ocular itching
- Conjunctival redness
Detailed description
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.
- Prednisolone phosphate
- Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 19 days
Controls:
Artificial Tears (Tears Naturale® II)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Experimental | Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%Prednisolone Sodium Phosphate Ophthalmic Solution, 1% |
| Placebo | Placebo comparator | Drug: Tears Naturale II Ophthalmic SolutionTears Naturale II Ophthalmic Solution, 1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age \& either sex, any race
- Willing and able to follow all instructions
- Positive history of ocular allergies
- Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
Key exclusion criteria (7 listed)
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy or lactating
- Use of disallowed medications
- Have ocular infections, or ocular conditions that could affect study parameters
- Have moderate to severe dry eye
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 |
|---|---|---|
| Prednisolone Sodium Phosphate Ophthalmic Solution 1%One drop in each eye, four times/day for 8 days. | Drug | Prednisolone |
| Tears Naturale II Ophthalmic Solutionone drop in each eye, four times/ day (QID) for 8 days | Drug | Placebo |
Primary outcome
Ocular Itching Change From Baseline to Day 11
Time frame: 5 minutes post-CAC
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
3 secondary outcomes
Conjunctival Redness Change From Baseline to Day 11
Time frame: 7 Minutes post-CAC
Episcleral Redness Change From Baseline to Day 6
Time frame: 7 minutes post-CAC
Ciliary Redness Change From Baseline to Day 6
Time frame: 7 minutes post-CAC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Allergic Conjunctivitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic
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.
Tarek Shazly, MD principal investigator
Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society
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 Prednisolone Sodium Phosphate Ophthalmic Solution 1% and Tears Naturale II Ophthalmic Solution in people with Allergic Conjunctivitis, run by ORA, Inc. 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 4 inclusion and 7 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 26 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change From Baseline to Day 11 (time frame: 5 minutes post-CAC). 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 26 Mar 2019.