Bilateral Conjunctivitis (Disorder)Phase 4NCT04708821
DEXTENZA Therapy for Treatment of Allergic Conjunctivitis
A Phase 4 study testing Dexamethasone ophthalmic insert 0.4Mg, 0.2% loteprednol etabonate ophthalmic suspension and olopatadine hydrochloride ophthalmic solution 0.7% in people with Bilateral Conjunctivitis (Disorder), run by Clinical Research Center of Florida at 1 site in United States.
Trial summary
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Conjunctivitis (Disorder)
- What is being tested?
- Dexamethasone ophthalmic insert 0.4Mg, 0.2% loteprednol etabonate ophthalmic suspension and olopatadine hydrochloride ophthalmic solution 0.7%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 2 Sep 2021
- 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
- Provide written informed consent and sign HIPAA form
- Be willing and able to follow all instructions and attend all study visits
- Be able and willing to discontinue wearing contact lenses throughout the study period
- Have a BCVA of ≥50 ETDRS letters (20/100 Snellen equivalent or better) in each eye as measured at Screening visit
- Have urine pregnancy testing for women considered capable of becoming pregnant; not be lactating; and agree to use a medically acceptable form of birth control throughout the study period
- Have a positive history of bilateral ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen as confirmed by the allergy testing at the Screening visit
Who cannot join
- • Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders
- Have any ocular condition that in the opinion of the Investigator could affect the subject's safety or study parameters (including, but not limited to uncontrolled narrow angle glaucoma, severe blepharitis, follicular conjunctivitis, iritis, pterygium, dry eye diagnosis, or active ocular infection)
- Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
- Use of systemic, inhaled, or nasal steroids
- Use of new systemic antihistamine use within 30 days of Screening visit
- Use of ocular or topical non-steroidal anti-inflammatory drugs (NSAIDs)
Show all 11Show fewer
- Use of lid scrubs
- Use of decongestants
- Use of immunotherapeutic agents
- Use of monoamine oxidase inhibitors (MAOIs)
- Have a congenital or ocular anomaly or anomaly of the punctum that may preclude placement of DEXTENZA
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
About this study
Official title: DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis
- Conditions
- Bilateral Conjunctivitis (Disorder)
- Being tested
- Dexamethasone ophthalmic insert 0.4Mg, 0.2% loteprednol etabonate ophthalmic suspension, olopatadine hydrochloride ophthalmic solution 0.7%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone ophthalmic insert 0.4MgDrug
Also called Dextenza
Dextenza 0.4Mg Ophthalmic Insert
0.2% loteprednol etabonate ophthalmic suspensionDrug
Also called ALREX
0.2% loteprednol etabonate ophthalmic suspension
olopatadine hydrochloride ophthalmic solution 0.7%Drug
Also called PAZEO
olopatadine hydrochloride ophthalmic solution 0.7%
| Study group | Role | What they receive |
|---|---|---|
| DEXTENZA | Experimental | DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use Receives: Drug: Dexamethasone ophthalmic insert 0.4Mg |
| Antihistamine | Active comparator | PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration. Receives: Drug: olopatadine hydrochloride ophthalmic solution 0.7% |
| Topical Steroid | Active comparator | ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Receives: Drug: 0.2% loteprednol etabonate ophthalmic suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start30 Apr 2021
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Conjunctivitis (Disorder)Studies 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708821
- Sponsor's protocol ID
- The Dex-AC Study
- Status last verified
- Apr 2022
- First submitted
- 15 Dec 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT04708821
- Acronym / sponsor ID
- The Dex-AC Study
- Conditions
- Bilateral Conjunctivitis (Disorder)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Clinical Research Center of FloridaUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 14 Jan 2021 (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 prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DEXTENZA | Experimental | Drug: Dexamethasone ophthalmic insert 0.4MgDEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use |
| Antihistamine | Active comparator | Drug: olopatadine hydrochloride ophthalmic solution 0.7%PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration. |
| Topical Steroid | Active comparator | Drug: 0.2% loteprednol etabonate ophthalmic suspensionALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years of age
- Provide written informed consent and sign HIPAA form
- Be willing and able to follow all instructions and attend all study visits
- Be able and willing to discontinue wearing contact lenses throughout the study period
- Have a BCVA of ≥50 ETDRS letters (20/100 Snellen equivalent or better) in each eye as measured at Screening visit
Key exclusion criteria (11 listed)
- • Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders
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 |
|---|---|---|
| Dexamethasone ophthalmic insert 0.4MgAlso: DextenzaDextenza 0.4Mg Ophthalmic Insert | Drug | DEXTENZA |
| 0.2% loteprednol etabonate ophthalmic suspensionAlso: ALREX0.2% loteprednol etabonate ophthalmic suspension | Drug | Topical Steroid |
| olopatadine hydrochloride ophthalmic solution 0.7%Also: PAZEOolopatadine hydrochloride ophthalmic solution 0.7% | Drug | Antihistamine |
Primary outcome
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
Time frame: 30 days
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
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 13 Apr 2022.
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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 Dexamethasone ophthalmic insert 0.4Mg, 0.2% loteprednol etabonate ophthalmic suspension and olopatadine hydrochloride ophthalmic solution 0.7% in people with Bilateral Conjunctivitis (Disorder), run by Clinical Research Center of Florida 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 7 inclusion and 11 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 13 Apr 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?
Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit) (time frame: 30 days). 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 13 Apr 2022.