Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
Public ClinicalTrials.gov record NCT04630158. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04630158
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 21, 2021 (Actual)
- Primary completion
- Jun 7, 2023 (Actual)
- Completion
- Jun 8, 2023 (Actual)
- Last update posted
- Oct 9, 2024
2021 – 2023
United States locations
- U.S. sites
- 24
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Valley Eye Medical Group | Mission Hills | California | 91345 | — |
| NVISION Eye Centers | Newport Beach | California | 92660 | — |
| Stanford Eye Laser Center | Palo Alto | California | 94303 | — |
| Gordon Schanzlin New Vision Inst | San Diego | California | 92122 | — |
| Novartis Investigative Site | Coral Springs | Florida | 33067 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32256 | — |
| Novartis Investigative Site | Miami | Florida | 33136 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Boston Sight | Needham | Massachusetts | 02494 | — |
| Univ of MI Kellogg Eye Center . | Ann Arbor | Michigan | 48105 | — |
| Duke Univ Medical Center Ophthalmology | Durham | North Carolina | 27710 | — |
| Bergstrom Eye Research LLC | Fargo | North Dakota | 58103 | — |
| University of Pennsylvania . | Philadelphia | Pennsylvania | 19104 | — |
| Chattanooga Eye Institute | Chattanooga | Tennessee | 37411 | — |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | — |
| Advancing Vision Research LLC | Smyrna | Tennessee | 37167 | — |
| Novartis Investigative Site | Houston | Texas | 77025 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | Houston | Texas | 77074 | — |
| Lake Travis Eye and Laser Ctr | Lakeway | Texas | 78738 | — |
| Stacy R Smith MD PC | Salt Lake City | Utah | 84117 | — |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | — |
| Rainier Clinical Research Center Inc . | Renton | Washington | 98057 | — |
| Periman Eye Institute | Seattle | Washington | 98119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04630158, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04630158 live on ClinicalTrials.gov.