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NCT04599933 · ClinicalTrials.gov registry record · Phase 3
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
A Phase 3 study, sponsored by Orasis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
NCT04599933: Completed Phase 3 study, sponsored by Orasis Pharmaceuticals.
NCT04599933 is a Phase 3 study that has completed, run by Orasis Pharmaceuticals. The registered enrollment target is 309 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04599933, a Phase 3 study, has completed, sponsored by Orasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
Study Summary
This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
Primary Outcome
The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
Interventions
- DRUG Vehicle
- DRUG CSF-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2020-10-18 |
| Est. Completion | 2022-02-19 |
| Phase | Phase 3 |
What the finished NCT04599933 record still lists
NCT04599933 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT04599933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04599933 about?
NCT04599933 is a clinical study titled "An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)". This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
What is the current status of trial NCT04599933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2020-10-18. Estimated completion is 2022-02-19.
What interventions are being tested in trial NCT04599933?
The interventions under investigation include: Vehicle (DRUG), CSF-1 (DRUG).
Who is sponsoring clinical trial NCT04599933?
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 NCT04599933's enrollment target sits among peer trials
309 1109th of 2000 higher than 889 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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