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

NCT07128628
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
443
clinicaltrials.gov
Lead sponsor
Bausch & Lomb Incorporated
clinicaltrials.gov
Start date
2025-10-24
clinicaltrials.gov
Number of sites
32
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
clinicaltrials.gov
Short title
A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-05-28
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First posted
2025-08-19
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Registry last updated
2026-07-14
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Primary completion date
2026-05-28
clinicaltrials.gov
Start date
2025-10-24
clinicaltrials.gov

Actual participants
443
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Participants
443
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
2
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Number of sites
32
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bausch & Lomb Incorporated
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07128628
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07128628
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Total corneal fluorescein staining change from baseline

    Timeframe: Baseline, day 29

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)