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Completed NCT07128628

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

Conditions: Dry Eye Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 443
Sponsor: Bausch & Lomb Incorporated

Location: Eye Doctors of Arizona, PLLC Phoenix Arizona

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

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07128628). StuddyBuddy aggregates publicly available trial information.