A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
Trial Parameters
Eligibility Fast-Check
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Brief 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-corre