Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Ocular Pain
In brief
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.
Key facts
- Study ID
- NCT04630158
- Run by
- Novartis Pharmaceuticals
- People needed
- 153
- Starts
- 2021-04-21
- Expected to finish
- 2023-06-08
- Last updated by the study team
- 2024-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- North Valley Eye Medical Group — Mission Hills, California, United States
- NVISION Eye Centers — Newport Beach, California, United States
- Stanford Eye Laser Center — Palo Alto, California, United States
- Gordon Schanzlin New Vision Inst — San Diego, California, United States
- Novartis Investigative Site — Coral Springs, Florida, United States
- Novartis Investigative Site — Jacksonville, Florida, United States
- Novartis Investigative Site — Miami, Florida, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Boston Sight — Needham, Massachusetts, United States
- Univ of MI Kellogg Eye Center . — Ann Arbor, Michigan, United States
- Duke Univ Medical Center Ophthalmology — Durham, North Carolina, United States
- Bergstrom Eye Research LLC — Fargo, North Dakota, United States
- University of Pennsylvania . — Philadelphia, Pennsylvania, United States
- Chattanooga Eye Institute — Chattanooga, Tennessee, United States
- Novartis Investigative Site — Memphis, Tennessee, United States
- Advancing Vision Research LLC — Smyrna, Tennessee, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Houston, Texas, United States
- Lake Travis Eye and Laser Ctr — Lakeway, Texas, United States
- Stacy R Smith MD PC — Salt Lake City, Utah, United States
- Piedmont Eye Center — Lynchburg, Virginia, United States
- Rainier Clinical Research Center Inc . — Renton, Washington, United States
- Periman Eye Institute — Seattle, Washington, United States
- Novartis Investigative Site — Sapporo, Hokkaido, Japan
Full record on ClinicalTrials.gov
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