Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)

Summary

The study was designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (5 mg/mL and 15 mg/mL) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and chronicity confirmed during the observational period. The study also determined the optimal dose to carry forward for further development.

Timeline

Start

2021-04-21

Primary completion

2023-06-07

Completion

2023-06-08

Outcome

Missed primary endpoint

registry analysis (superiority test); SAF312 15 mg/mL vs SAF312 Placebo; p = 0.930; Least Square (LS) mean difference 1.6 (95% CI -8.5 to 11.7) NCT04630158 ↗

registry analysis (superiority test); SAF312 5mg/mL vs SAF312 Placebo; p = 0.699; Least Square (LS) mean difference 3.7 (95% CI -6.4 to 13.8) NCT04630158 ↗

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	5 mg/ml	Topical
Subject	SAF312	Unknown	15 mg/ml	Topical

Indications