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

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 Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06424444

Enrollment

421

Registered

2024-05-22

Start date

2024-04-29

Completion date

2024-11-03

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

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

Interventions

DRUGReproxalap ophthalmic solution (0.25%)

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

DRUGVehicle ophthalmic solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026