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

Not Applicable

Not yet recruiting

• Conditions: Dry Eye Disease
• Interventions: Drug: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination; Drug: Lifitegrast; Drug: Perfluorohexyloctane; Drug: Vehicle

• Registration Number: NCT07128628
• Lead Sponsor: Bausch & Lomb Incorporated

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-11-01
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 423

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 following 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Lifitegrast/Perfluorohexyloctane Fixed Dose Combination	-
Arm 2	Lifitegrast	-
Arm 3	Perfluorohexyloctane	-
Arm 4	Vehicle	-
Arm 5	Vehicle	-
Arm 6	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Total corneal fluorescein staining change from baseline	Baseline, day 29