A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease

Official Title
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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Conditions
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Dry Eye Disease

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


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; 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 within 90 days of Visit 1; 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%) QID for four weeks followed by BID for two weeks.<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution QID for four weeks followed by BID for two weeks.<br> | Drug: Placebo Comparator<br>* Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).<br>|
| Experimental: Reproxalap Ophthalmic Solution (0.25%) QID for four weeks followed by BID for 11 months.<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution QID for four weeks followed by BID for 11 months.<br> | Drug: Placebo Comparator<br>* Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular treatment emergent adverse events (TEAEs) | Percentages of subjects with ocular treatment-emergent adverse events (TEAEs). | Safety assessment period (Day 1 through Day 28 or Day 1 through Day 360) |