A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
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
1 other identifier
interventional
443
1 country
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2026
CompletedJuly 14, 2026
July 1, 2026
7 months
August 6, 2025
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total corneal fluorescein staining change from baseline
Baseline, day 29
Study Arms (6)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORArm 4
PLACEBO COMPARATORArm 5
PLACEBO COMPARATORArm 6
PLACEBO COMPARATORInterventions
Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
Eligibility Criteria
You may qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Eye Doctors of Arizona, PLLC
Phoenix, Arizona, 85028, United States
Global Research Management, Inc.
Glendale, California, 91204, United States
SoCal Eye - Lakewood Clinic
Long Beach, California, 90805, United States
LoBue Laser and Eye Medical Center
Murrieta, California, 92562, United States
Eye Research Foundation, Inc.
Newport Beach, California, 92663, United States
Wolstan and Goldberg Eye Associates
Torrance, California, 90505, United States
Segal Drug Trials/Office of Bruce A Segal, MD
Delray Beach, Florida, 33484, United States
Bowden Eye and Associates
Jacksonville, Florida, 32256, United States
Shettle Eye Research, Inc
Largo, Florida, 33773, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260, United States
Midwest Cornea Associates LLC
Carmel, Indiana, 46032, United States
Kannarr Eye Care, LLC
Pittsburg, Kansas, 66762, United States
Vance Thompson Vision - Alexandria
Alexandria, Minnesota, 56308, United States
Complete Eye Care of Medina
Medina, Minnesota, 55340, United States
Insight Eyecare Specialties, Inc.
Kansas City, Missouri, 64111, United States
Moyes Eye Center, P.C.
Kansas City, Missouri, 64154, United States
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090, United States
Opthalmic consultants of Long Island
Garden City, New York, 11530, United States
Rochester Ophthalmological Group,PC
Rochester, New York, 14618, United States
Asheville Eye Associates
Asheville, North Carolina, 28803, United States
Oculus Research
Garner, North Carolina, 27529, United States
CORE Inc.
Shelby, North Carolina, 28150, United States
Vance Thompson Vision - Fargo, ND
West Fargo, North Dakota, 58078, United States
Insight Research Clinic LLC.
Powell, Ohio, 43065, United States
Scott & Christie Eyecare Associates - The Surgery Center at Cranberry
Cranberry Township, Pennsylvania, 16066, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
Southern College of Optometry
Memphis, Tennessee, 38104, United States
Total Eye Care PA
Memphis, Tennessee, 38119, United States
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167, United States
Intouch Clinical Research Center
Houston, Texas, 77034, United States
Lake Travis Eye and Laser Center
Lakeway, Texas, 78738, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 19, 2025
Study Start
October 24, 2025
Primary Completion
May 28, 2026
Study Completion
May 28, 2026
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share