Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery

Summary

The purpose of this study is to determine if SAF312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (PRK) surgery

Timeline

Start

2016-12-01

Primary completion

2018-01-15

Completion

2018-02-21

Outcome

Met primary endpoint

registry analysis (superiority test); SAF312 vs Vehicle; p = 0.005; Mean Difference (Final Values) -11.1 (90% CI -17.54 to -4.71); Kenward-Roger method NCT02961062 ↗

registry analysis (superiority test); SAF312 vs Vehicle; p = 0.017; Median Difference (Final Values) -8.56 (90% CI -14.29 to -2.83); Kenward-Roger method NCT02961062 ↗

Publications

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAF312	Unknown	—	Topical

Indications

No indication recorded.