A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
Sponsored by Bausch & Lomb Incorporated
About this trial
Last updated a month ago
Study ID
BL-RX01-OPUSNG-1201
Status
Recruiting
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Started 6 months ago
What is this trial about?
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
What are the participation requirements?
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