A Clinical Trial to Assess Subjects With Dry Eye Disease.

Study Overview
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Brief Summary
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A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the 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 Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the 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

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: 18 years of age (either gender and any race); Reported history of dry eye for at least 6 months prior to Visit 1; Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1. Exclusion Criteria: Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial; Eye drop use within 2 hours of Visit 1; Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1; Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period; Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution administered 7 times over two consecutive days.<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution administered 7 times over two consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber | Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects. | The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1. | 
| Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) | Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort, 100 = maximal discomfort), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects. | The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1. | 
| Schirmer Test Change From Baseline After the First Dose on Day 1 | Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline and treatment group as fixed effects. | The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1. |