A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
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
Bausch & Lomb Incorporated
423 participants
Oct 24, 2025
INTERVENTIONAL
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
Eligibility
Inclusion Criteria7
- Voluntarily provide written informed consent
- ≥18 years of age
- Subject-reported history of DED OU for at least 6 months
- Same eye satisfies the criteria for dry eye signs at both screening and baseline/randomization
- The criteria for dry eye symptoms are met at both screening and baseline/randomization
- As needed (PRN) or scheduled use of non-prescription (OTC) artificial tear, gels, or lubricants for symptoms of dry eye within the past 30 days
- Able and willing to follow instructions, including participation in all trial assessments and visits
Exclusion Criteria6
- Known allergy or sensitivity to any study treatment (or any of its components)
- Best-corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or worse (50 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters; Snellen equivalent score of 20/100 or worse) at Visit 1 (Screening) or Visit 2 (baseline/randomization)
- Any clinically significant (CS) ocular surface slit-lamp findings at Visit 1 (Screening) or Visit 2 (baseline/randomization), or findings that may interfere with trial parameters in the opinion of the Investigator.
- Use of any of any ocular therapies within 30 days.
- Unable or unwilling to stop current topical dry eye treatments
- Additional criteria per protocol
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Interventions
Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
Topical ocular drop of lifitegrast administered for 4 weeks
Topical ocular drop of perfluorohexyloctane administered for 4 weeks
Topical ocular drop with no active ingredients administered for 4 weeks
Topical ocular drop with no active ingredients administered for 4 weeks
Topical ocular drop with no active ingredients administered for 4 weeks
Locations(32)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07128628