A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
ConditionDry Eye Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBausch & Lomb Incorporated
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lifitegrast/Perfluorohexyloctane Fixed Dose Combination
- Lifitegrast
- Perfluorohexyloctane
- Vehicle
- Vehicle
- Vehicle
Treatment groups
423 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov