> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-the-safety-and-efficacy-of-a-fixed-dose-84bbf443-32bc-41dd-874c-453b479bc646 > Record changed: 2026-10-13 # A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease NCT07128628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) Participants 443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) Lead sponsor Bausch & Lomb Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) Start date 2025-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) Number of sites 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Short title** A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Dates **Completion date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **First posted** 2025-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Registry last updated** 2026-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Primary completion date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Start date** 2025-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Size and sites **Actual participants** 443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Participants** 443 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Number of sites** 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Lead sponsor** Bausch & Lomb Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Identifiers **Registry ID** NCT07128628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **ClinicalTrials.gov ID** NCT07128628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Outcomes ### Primary outcomes 1. Total corneal fluorescein staining change from baseline Timeframe: Baseline, day 29 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Sites - Eye Doctors of Arizona, PLLCPhoenix, United States - Global Research Management, Inc.Glendale, United States - SoCal Eye - Lakewood ClinicLong Beach, United States - LoBue Laser and Eye Medical CenterMurrieta, United States - Eye Research Foundation, Inc.Newport Beach, United States - Wolstan and Goldberg Eye AssociatesTorrance, United States - Segal Drug Trials/Office of Bruce A Segal, MDDelray Beach, United States - Bowden Eye and AssociatesJacksonville, United States - Shettle Eye Research, IncLargo, United States - Clayton Eye Clinical Research, LLCMorrow, United States - Midwest Cornea Associates LLCCarmel, United States - Kannarr Eye Care, LLCPittsburg, United States - Vance Thompson Vision - AlexandriaAlexandria, United States - Complete Eye Care of MedinaMedina, United States - Insight Eyecare Specialties, Inc.Kansas City, United States - Moyes Eye Center, P.C.Kansas City, United States - Ophthalmology Consultants, Ltd.St Louis, United States - Comprehensive Eye Care Ltd.Washington, United States - Opthalmic consultants of Long IslandGarden City, United States - Rochester Ophthalmological Group,PCRochester, United States - Asheville Eye AssociatesAsheville, United States - Oculus ResearchGarner, United States - CORE Inc.Shelby, United States - Vance Thompson Vision - Fargo, NDWest Fargo, United States - Insight Research Clinic LLC.Powell, United States And 7 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128628) ## Related records ### Drugs (2) - [Lifitegrast sodium](https://trialight.com/data/asset/lifitegrast-sodium-b020c8d8-25e0-4450-b699-9d4068a9d60a.md) - [Perfluorohexyloctane](https://trialight.com/data/asset/perfluorohexyloctane-a636f5f3-a738-40e0-827a-c242866ab0fc.md) ### Lead sponsors (1) - [Bausch & Lomb Incorporated](https://trialight.com/data/company/bausch-lomb-incorporated-c692b52d-2b3d-42dd-8339-8b59ea05d1d3.md) ### Conditions (1) - [Dry eye syndrome](https://trialight.com/data/condition/dry-eye-syndrome-41ae8541-7903-50ab-9b50-168da1d2f619.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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