A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy 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, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease

Official Title
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A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Reproxalap Ophthalmic Solution (0.25%)
* Drug: Reproxalap Ophthalmic Solution (0.1%)
* Drug: Vehicle Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age of either gender and any race; Have a reported history of dry eye for at least 6 months prior to Visit 1; Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1; Exclusion Criteria: Have any 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; Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have used any eye drops within 2 hours of Visit 1; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1; Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; Be using or anticipate using 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%)<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.<br>|
| Experimental: Reproxalap Ophthalmic Solution (0.1%)<br> | Drug: Reproxalap Ophthalmic Solution (0.1%)<br>* Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution administered for approximately twelve weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of reproxalap formulations using adverse event query. | Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome. | Safety Assessment Period (Day -14 to Day 85) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of reproxalap on Lissamine green staining using the Ora Calibra® scale. | Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 85) | 
| Efficacy of reproxalap on fluorescein staining using the Ora Calibra® scale. | Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 85) | 
| Efficacy of reproxalap on tear film break-up time (TFBUT©). | Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 85) | 
| Efficacy of reproxalap on ocular discomfort using the Ora Calibra® Ocular Discomfort scale. | Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 85) | 
| Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire. | Evaluate the symptoms of reproxalp in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 85) | 
| Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale. | Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome. | Efficacy assessment period (Day 1 through Day 85) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproxalap