Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects

Summary

SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop. The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.

Timeline

Start

2020-03-03

Primary completion

2020-11-03

Completion

2020-11-20

Outcome

Met primary endpoint

registry analysis (superiority test); SURF-201 vs Vehicle; p <0.001; z-test for proportions NCT04324359 ↗

release “Investigational therapy SURF-201 met all primary endpoints for the treatment of pain and inflammation following cataract surgery” surfaceophthalmics.com ↗

Publications

• Background Hosseini K, Gollamudi S, Reiser H, Walters T, Lindstrom RL. 0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects. Clin Ophthalmol. 2023 Aug 5;17:2219-2230. doi: 10.2147/OPTH.S419857. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SURF-201	Unknown	0.2 %	Topical

Indications

No indication recorded.