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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2024-11-03

Brief Summary

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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

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Reproxalap Ophthalmic Solution (0.25%)

Group Type EXPERIMENTAL

Reproxalap ophthalmic solution (0.25%)

Intervention Type DRUG

Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks

Vehicle Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle ophthalmic solution

Intervention Type DRUG

Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks

Interventions

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Reproxalap ophthalmic solution (0.25%)

Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks

Intervention Type DRUG

Vehicle ophthalmic solution

Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No