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NCT04630158 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT04630158: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04630158 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630158, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study 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.
Primary Outcome
The pain severity Visual Analogue Scale (VAS) was completed by the subject using an electronic diary. A vertical mark was placed on the horizontal scoring line (anchored with 'No Pain' on the left and 'Very Severe' pain on the right) to score the severity of ocular pain over the past 24 hours, with a range from 0 (min) to 100 (max). Higher scores indicate higher pain severity. A negative change from baseline is a positive outcome.
Interventions
- OTHER SAF312 Placebo
- DRUG SAF312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2023-06-08 |
| Phase | Phase 2 |
What the finished NCT04630158 record still lists
NCT04630158 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which SAF312 Placebo is the first listed.
NCT04630158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04630158 about?
NCT04630158 is a clinical study titled "Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)". 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 det...
What is the current status of trial NCT04630158?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2021-04-21. Estimated completion is 2023-06-08.
What interventions are being tested in trial NCT04630158?
The interventions under investigation include: SAF312 Placebo (OTHER), SAF312 (DRUG).
Who is sponsoring clinical trial NCT04630158?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04630158's enrollment target sits among peer trials
153 449th of 2000 higher than 1,549 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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