Overview

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)

Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Criteria
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.