A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

Phase 3

Recruiting

Interventions: Drug: Reproxalap ophthalmic solution (0.25%)
Drug: Vehicle ophthalmic solution

Brief Summary: A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap

Recruitment & Eligibility

Inclusion Criteria

at least 18 years of age;
written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria

ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
eye drops within 2 hours of Visit 1;
laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap ophthalmic solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Subject-reported ocular discomfort score over Week 1 to Week 6	From Day -14 to Day 43	Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"

Secondary Outcome Measures

Name	Time	Method

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