A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease

Study Overview
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Brief Summary
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A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Official Title
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A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Reproxalap Ophthalmic Solution (0.25%)
* Drug: Vehicle Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eighteen (18) to 70 years of age at the time of screening (either gender and any race) Ability to provide written informed consent Reported history of dry eye for at least 6 months prior to screening Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening Exclusion Criteria: Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening Contact lens use within 7 days of screening or anticipate using contact lenses during the trial Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period Women of childbearing potential (WOCBP) who are pregnant and nursing If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control. Known allergy and/or sensitivity to reproxalap or the drug product vehicle A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reproxalap Ophthalmic Solution (0.25%)<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution dosed six times over two consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in conjunctival redness in a dry eye chamber | Conjunctival redness assessed on a 9 point scale using half unit increments using the modified Validated Bulbar Redness scale (0 None (better) - 4 Extremely Severe (worse)) | On the second day of two consecutive dosing days for both crossover periods | 
| Schirmer's test mean change from baseline | Assessed using a sterile Schirmer's test strip | On the first day of two consecutive dosing days for both crossover periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer's test ≥10mm responder analysis of change from baseline | Assessed using a sterile Schirmer's test strip | On the first day of two consecutive dosing days for both crossover periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye disease, reproxalap, Aldeyra, ADX-102