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NCT03885011 · ClinicalTrials.gov registry record · Phase 2
A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia
A Phase 2 study, sponsored by Orasis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
NCT03885011: Completed Phase 2 study, sponsored by Orasis Pharmaceuticals.
NCT03885011 is a Phase 2 study that has completed, run by Orasis Pharmaceuticals. The registered enrollment target is 166 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03885011, a Phase 2 study, has completed, sponsored by Orasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
Study Summary
This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.
Primary Outcome
Number of subjects with a ≥ 3-line gain in near BDCVA (at 40 cm) at 1 hour post dose after 1 week treatment with CSF-1-Fixed Dose Combination (FDC) low dose (pilocarpine HCl 0.2% + diclofenac 0.006%) or pilocarpine HCl 0.2% alone or diclofenac 0.006% alone
Interventions
- DRUG CSF-1
- DRUG CSF-1 Component #1
- DRUG CSF-1 Component #2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2019-07-26 |
| Phase | Phase 2 |
What the finished NCT03885011 record still lists
NCT03885011 is an interventional study that assigns participants to a tested intervention. The registered 166 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 (25% higher).
The record links to 0 conditions, and to 3 interventions - of which CSF-1 is the first listed.
NCT03885011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03885011 about?
NCT03885011 is a clinical study titled "A Multi-Center, Double-Masked Evaluation of the Efficacy and Safety of CSF-1 in the Treatment of Presbyopia". This is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of CSF-1 in the treatment of presbyopia.
What is the current status of trial NCT03885011?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2019-02-26. Estimated completion is 2019-07-26.
What interventions are being tested in trial NCT03885011?
The interventions under investigation include: CSF-1 (DRUG), CSF-1 Component #1 (DRUG), CSF-1 Component #2 (DRUG).
Who is sponsoring clinical trial NCT03885011?
This trial is sponsored by Orasis Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03885011's enrollment target sits among peer trials
166 406th of 2000 higher than 1,591 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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