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