Dry Eye Disease
Conditions
Brief 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
Interventions
DRUGLifitegrast/Perfluorohexyloctane Fixed Dose Combination
Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
DRUGLifitegrast
Topical ocular drop of lifitegrast administered for 4 weeks
DRUGPerfluorohexyloctane
Topical ocular drop of perfluorohexyloctane administered for 4 weeks
DRUGVehicle
Topical ocular drop with no active ingredients administered for 4 weeks
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will include subjects who meet all of the following inclusion criteria: * 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 criteria
This study will exclude subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total corneal fluorescein staining change from baseline | Baseline, day 29 |
Countries
United States
Outcome results
None listed