At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
SAF312 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-week Parallel Group, Randomized, Placebo-controlled, Double-blinded, Multi-center Study to Evaluate Efficacy and Safety of 2 Concentrations of SAF312 Eye Drops (5 mg/ml and 15 mg/ml) Used Twice-daily in the Treatment of Post-operative Corneal Induced Chronic Pain (CICP) Following Photorefractive Keratectomy (PRK) or Laser-assisted in Situ Keratomileusis (LASIK) Surgeries
In Brief
A Phase 2 clinical trial evaluating SAF312 Placebo and SAF312 for Chronic Ocular Pain. Completed, enrolled 153 participants across 28 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Ocular Pain
CountriesJapan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartApr 2021
Primary CompletionJun 2023
Study CompletionJun 2023
TodayJul 2026
First PostedNov 16, 2020
Enrollment StartApr 21, 2021
Primary CompletionJun 7, 2023
Study CompletionJun 8, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.6 years ago
Interventions
SAF312 Placeboother
Topical ocular, suspension eye drops
SAF312drug
Topical ocular, suspension eye drops