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RECRUITING
NCT07128628
PHASE2

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease

Sponsor: Bausch & Lomb Incorporated

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

423

Start Date

2025-10-24

Completion Date

2026-11

Last Updated

2026-03-13

Healthy Volunteers

No

Conditions

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, United States

Global Research Management, Inc.

Glendale, California, United States

SoCal Eye - Lakewood Clinic

Long Beach, California, United States

LoBue Laser and Eye Medical Center

Murrieta, California, United States

Eye Research Foundation, Inc.

Newport Beach, California, United States

Wolstan and Goldberg Eye Associates

Torrance, California, United States

Segal Drug Trials/Office of Bruce A Segal, MD

Delray Beach, Florida, United States

Bowden Eye and Associates

Jacksonville, Florida, United States

Shettle Eye Research, Inc

Largo, Florida, United States

Clayton Eye Clinical Research, LLC

Morrow, Georgia, United States

Midwest Cornea Associates LLC

Carmel, Indiana, United States

Kannarr Eye Care, LLC

Pittsburg, Kansas, United States

Vance Thompson Vision - Alexandria

Alexandria, Minnesota, United States

Complete Eye Care of Medina

Medina, Minnesota, United States

Insight Eyecare Specialties, Inc.

Kansas City, Missouri, United States

Moyes Eye Center, P.C.

Kansas City, Missouri, United States

Ophthalmology Consultants, Ltd.

St Louis, Missouri, United States

Comprehensive Eye Care Ltd.

Washington, Missouri, United States

Opthalmic consultants of Long Island

Garden City, New York, United States

Rochester Ophthalmological Group,PC

Rochester, New York, United States

Asheville Eye Associates

Asheville, North Carolina, United States

Oculus Research

Garner, North Carolina, United States

CORE Inc.

Shelby, North Carolina, United States

Vance Thompson Vision - Fargo, ND

West Fargo, North Dakota, United States

Insight Research Clinic LLC.

Powell, Ohio, United States

Scott & Christie Eyecare Associates - The Surgery Center at Cranberry

Cranberry Township, Pennsylvania, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Southern College of Optometry

Memphis, Tennessee, United States

Total Eye Care PA

Memphis, Tennessee, United States

Advancing Vision Research, LLC

Smyrna, Tennessee, United States

Intouch Clinical Research Center

Houston, Texas, United States

Lake Travis Eye and Laser Center

Lakeway, Texas, United States