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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1
  • Drug: Lifitegrast/Perfluorohexyloctane Fixed Dose Combination
    Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
Active Comparator
Arm 2
  • Drug: Lifitegrast
    Topical ocular drop of lifitegrast administered for 4 weeks
Active Comparator
Arm 3
  • Drug: Perfluorohexyloctane
    Topical ocular drop of perfluorohexyloctane administered for 4 weeks
Placebo Comparator
Arm 4
  • Drug: Vehicle
    Topical ocular drop with no active ingredients administered for 4 weeks
Placebo Comparator
Arm 5
  • Drug: Vehicle
    Topical ocular drop with no active ingredients administered for 4 weeks
Placebo Comparator
Arm 6
  • Drug: Vehicle
    Topical ocular drop with no active ingredients administered for 4 weeks

Recruiting Locations

Eye Doctors of Arizona, PLLC
Phoenix, Arizona 85028

Global Research Management, Inc.
Glendale, California 91204

SoCal Eye - Lakewood Clinic
Long Beach, California 90805

LoBue Laser and Eye Medical Center
Murrieta, California 92562

Eye Research Foundation, Inc.
Newport Beach, California 92663

Wolstan and Goldberg Eye Associates
Torrance, California 90505

Segal Drug Trials/Office of Bruce A Segal, MD
Delray Beach, Florida 33484

Bowden Eye and Associates
Jacksonville, Florida 32256

Shettle Eye Research, Inc
Largo, Florida 33773

Clayton Eye Clinical Research, LLC
Morrow, Georgia 30260

Midwest Cornea Associates LLC
Carmel, Indiana 46032

Kannarr Eye Care, LLC
Pittsburg, Kansas 66762

Vance Thompson Vision - Alexandria
Alexandria, Minnesota 56308

Complete Eye Care of Medina
Medina, Minnesota 55340

Insight Eyecare Specialties, Inc.
Kansas City, Missouri 64111

Moyes Eye Center, P.C.
Kansas City, Missouri 64154

Ophthalmology Consultants, Ltd.
St Louis, Missouri 63131

Comprehensive Eye Care Ltd.
Washington, Missouri 63090

Opthalmic consultants of Long Island
Garden City, New York 11530

Rochester Ophthalmological Group,PC
Rochester, New York 14618

Asheville Eye Associates
Asheville, North Carolina 28803

Oculus Research
Garner, North Carolina 27529

CORE Inc.
Shelby, North Carolina 28150

Vance Thompson Vision - Fargo, ND
West Fargo, North Dakota 58078

Insight Research Clinic LLC.
Powell, Ohio 43065

Scott & Christie Eyecare Associates - The Surgery Center at Cranberry
Cranberry Township, Pennsylvania 16066

West Bay Eye Associates
Warwick, Rhode Island 02888

Southern College of Optometry
Memphis, Tennessee 38104

Total Eye Care PA
Memphis, Tennessee 38119

Advancing Vision Research, LLC
Smyrna, Tennessee 37167

Intouch Clinical Research Center
Houston, Texas 77034

Lake Travis Eye and Laser Center
Lakeway, Texas 78738

More Details

Status
Recruiting
Sponsor
Bausch & Lomb Incorporated

Study Contact

Study Manager Bausch and Lomb
2147262850
BLCTgovcentral@bausch.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.