The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 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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The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 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 |
| --- | --- | --- |
| Schirmer's Test overall mean change from baseline | Measured using a sterile Schirmer's Test strip | Day 1 | 
| Schirmer's Test greater than or equal to 10mm (millimeter) responder analysis of change from baseline. | Measured using a sterile Schirmer's Test strip | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival redness assessed via digital photography over 90 minutes in the dry eye chamber | Digital photography of conjunctival redness on a 0 to 4 (normal - severe) scale | Day 2 |