A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

EYP-DIP-301

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

2023-03-01

2024-04-01

2024-04-01

Not yet recruiting

Early phase I

150

Inclusion Criteria: * Male or female subjects at least 40 years of age scheduled for cataract surgery * Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye * Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye. Exclusion Criteria: * Use of any corticosteroids within 7 days prior to Day 0 * Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days * Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2022-09-22