NCT04324359

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

A Multicenter, Randomized, Double-Masked Study To Compare The Ocular Safety, Tolerability, And Efficacy Of A Topical 0.2% Ophthalmic Corticosteroid Solution (SURF-201) To Vehicle In Cataract Surgery Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Surface Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-surgical Ocular Inflammation
• Post-surgical Ocular Pain

Interventions

Type	Name	Description
DRUG	SURF-201	One drop twice daily (BID) in the study eye for 16 days.
DRUG	Placebo	One drop twice daily (BID) in the study eye for 16 days.

Timeline

• Start date: 2020-03-03
• Primary completion: 2020-11-03
• Completion: 2020-11-20
• First posted: 2020-03-27
• Last updated: 2025-01-15
• Results posted: 2023-10-18

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study