A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
NCT07128628 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 423
Last updated 2026-03-13
Summary
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
Conditions
Interventions
- DRUG
-
Vehicle
Topical ocular drop with no active ingredients administered for 4 weeks
- DRUG
-
Lifitegrast/Perfluorohexyloctane Fixed Dose Combination
Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
- DRUG
-
Lifitegrast
Topical ocular drop of lifitegrast administered for 4 weeks
- DRUG
-
Perfluorohexyloctane
Topical ocular drop of perfluorohexyloctane administered for 4 weeks
- DRUG
-
Vehicle
Topical ocular drop with no active ingredients administered for 4 weeks
- DRUG
-
Vehicle
Topical ocular drop with no active ingredients administered for 4 weeks
Sponsors & Collaborators
-
Bausch & Lomb Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-24
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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