Overview
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
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
