NCT05191706

Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: EyePoint Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Dexamethasone	single anterior chamber injection
DRUG	Prednisolone Acetate Ophthalmic	topical administration four times a day for 28 days, followed by treatment taper

Timeline

• Start date: 2022-01-04
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2022-01-13
• Last updated: 2025-04-03

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study