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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bausch & Lomb Incorporated
Study ID
NCT07128628
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lifitegrast/Perfluorohexyloctane Fixed Dose Combination — DRUG
    Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
  • Lifitegrast — DRUG
    Topical ocular drop of lifitegrast administered for 4 weeks
  • Perfluorohexyloctane — DRUG
    Topical ocular drop of perfluorohexyloctane administered for 4 weeks
  • Vehicle — DRUG
    Topical ocular drop with no active ingredients administered for 4 weeks
  • Vehicle — DRUG
    Topical ocular drop with no active ingredients administered for 4 weeks
  • Vehicle — DRUG
    Topical ocular drop with no active ingredients administered for 4 weeks

Study Details

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 Dates

Start date
Oct 24, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
423 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
  • Active Comparator: Arm 2
  • Active Comparator: Arm 3
  • Placebo Comparator: Arm 4
  • Placebo Comparator: Arm 5
  • Placebo Comparator: Arm 6

Primary Outcome Measure

Total corneal fluorescein staining change from baseline [ Time Frame: Baseline, day 29 ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Eye Doctors of Arizona, PLLCPhoenixArizona85028-
Global Research Management, Inc.GlendaleCalifornia91204-
SoCal Eye - Lakewood ClinicLong BeachCalifornia90805-
LoBue Laser and Eye Medical CenterMurrietaCalifornia92562-
Eye Research Foundation, Inc.Newport BeachCalifornia92663-
Wolstan and Goldberg Eye AssociatesTorranceCalifornia90505-
Segal Drug Trials/Office of Bruce A Segal, MDDelray BeachFlorida33484-
Bowden Eye and AssociatesJacksonvilleFlorida32256-
Shettle Eye Research, IncLargoFlorida33773-
Clayton Eye Clinical Research, LLCMorrowGeorgia30260-
Midwest Cornea Associates LLCCarmelIndiana46032-
Kannarr Eye Care, LLCPittsburgKansas66762-
Vance Thompson Vision - AlexandriaAlexandriaMinnesota56308-
Complete Eye Care of MedinaMedinaMinnesota55340-
Insight Eyecare Specialties, Inc.Kansas CityMissouri64111-
Moyes Eye Center, P.C.Kansas CityMissouri64154-
Ophthalmology Consultants, Ltd.St LouisMissouri63131-
Comprehensive Eye Care Ltd.WashingtonMissouri63090-
Opthalmic consultants of Long IslandGarden CityNew York11530-
Rochester Ophthalmological Group,PCRochesterNew York14618-
Asheville Eye AssociatesAshevilleNorth Carolina28803-
Oculus ResearchGarnerNorth Carolina27529-
CORE Inc.ShelbyNorth Carolina28150-
Vance Thompson Vision - Fargo, NDWest FargoNorth Dakota58078-
Insight Research Clinic LLC.PowellOhio43065-
Scott & Christie Eyecare Associates - The Surgery Center at CranberryCranberry TownshipPennsylvania16066-
West Bay Eye AssociatesWarwickRhode Island02888-
Southern College of OptometryMemphisTennessee38104-
Total Eye Care PAMemphisTennessee38119-
Advancing Vision Research, LLCSmyrnaTennessee37167-
Intouch Clinical Research CenterHoustonTexas77034-
Lake Travis Eye and Laser CenterLakewayTexas78738-

Find similar trials in Phoenix, AZ

By research site
Eye Doctors of Arizona, PLLC· Phoenix, AZGlobal Research Management, Inc.· Glendale, CASoCal Eye - Lakewood Clinic· Long Beach, CALoBue Laser and Eye Medical Center· Murrieta, CAEye Research Foundation, Inc.· Newport Beach, CAWolstan and Goldberg Eye Associates· Torrance, CA

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