The study is designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (dose 1 and dose 2) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and chronicity confirmed during the observational period. The study will also determine the optimal dose to carry forward for further development.
This study is a Phase 2 randomized, double-blinded, multi-center, parallel group, placebo-controlled evaluation of the safety and efficacy of SAF312, 5 mg/ml and 15 mg/ml eye drops versus placebo used twice-daily in both eyes for 12 weeks. Eligible subjects will have undergone refractive surgery (i.e., PRK, LASIK, LASEK, RK, or SMILE) in both eyes or cataract surgery in both eyes with or without refractive enhancement in one or both eyes at least 4 months prior to Screening, and have been suffering from chronic ocular pain as a result of their surgery. Eligible patients must also demonstrate chronicity of the pain at Baseline Visit as described in inclusion criteria. Overall approximately 150 subjects will be enrolled in the study and randomized to one of 3 study arms in 1:1:1 ratio
| Condition | Chronic Ocular Pain |
|---|---|
| Treatment | SAF312, SAF312 Placebo |
| Clinical Study Identifier | NCT04630158 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 6 June 2023 |
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