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

Completed · Phase 2

Conditions studied: Dry Eye Disease

In brief

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 facts

Study ID

NCT07128628

Run by

Bausch & Lomb Incorporated

People needed

443

Starts

2025-10-24

Expected to finish

2026-05-28

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• This study will exclude subjects who meet any of the following exclusion criteria (Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study):
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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