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

Summary

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 instructi…

Interventions

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
Drug
Vehicle
Topical ocular drop with no active ingredients administered for 4 weeks

Locations (32)

Eye Doctors of Arizona, PLLC
Phoenix, Arizona
Global Research Management, Inc.
Glendale, California
SoCal Eye - Lakewood Clinic
Long Beach, California
LoBue Laser and Eye Medical Center
Murrieta, California
Eye Research Foundation, Inc.
Newport Beach, California
Wolstan and Goldberg Eye Associates
Torrance, California