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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: This study will include subjects who meet all of the following Who May Qualify: - Voluntarily provide written willing to sign a consent form - ≥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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Lifitegrast/Perfluorohexyloctane Fixed Dose Combination

Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks

DRUG

Lifitegrast

Topical ocular drop of lifitegrast administered for 4 weeks

DRUG

Perfluorohexyloctane

Topical ocular drop of perfluorohexyloctane administered for 4 weeks

DRUG

Vehicle

Topical ocular drop with no active ingredients administered for 4 weeks

DRUG

Vehicle

Topical ocular drop with no active ingredients administered for 4 weeks

DRUG

Vehicle

Topical ocular drop with no active ingredients administered for 4 weeks

Locations (20)

Eye Doctors of Arizona, PLLC
Phoenix, Arizona, United States
Global Research Management, Inc.
Glendale, California, United States
SoCal Eye - Lakewood Clinic
Long Beach, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Eye Research Foundation, Inc.
Newport Beach, California, United States
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Segal Drug Trials/Office of Bruce A Segal, MD
Delray Beach, Florida, United States
Bowden Eye and Associates
Jacksonville, Florida, United States
Shettle Eye Research, Inc
Largo, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Midwest Cornea Associates LLC
Carmel, Indiana, United States
Kannarr Eye Care, LLC
Pittsburg, Kansas, United States
Vance Thompson Vision - Alexandria
Alexandria, Minnesota, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Insight Eyecare Specialties, Inc.
Kansas City, Missouri, United States
Moyes Eye Center, P.C.
Kansas City, Missouri, United States
Ophthalmology Consultants, Ltd.
St Louis, Missouri, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, United States
Opthalmic consultants of Long Island
Garden City, New York, United States
Rochester Ophthalmological Group,PC
Rochester, New York, United States