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NCT04599972 · ClinicalTrials.gov registry record · Phase 3
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
A Phase 3 study of Presbyopia, sponsored by Orasis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 18
- Study locations
NCT04599972: Completed Phase 3 study of Presbyopia, sponsored by Orasis Pharmaceuticals.
NCT04599972 is a Phase 3 study of Presbyopia that has completed, run by Orasis Pharmaceuticals. The registered enrollment target is 304 participants, above the 263-participant average among 38 other Presbyopia trials with a reported enrollment target (16% higher). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04599972, a Phase 3 study of Presbyopia, has completed, sponsored by Orasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 18
- Study locations
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.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG CSF-1
Study Locations (18)
California
- Orasis Investigative Site - Garden Grove
- Orasis Investigative Site - Mission Hills
- Orasis Investigative Site - Newport Beach
- Orasis Investigative Site - Petaluma
Arizona
- Orasis Investigative Site - Chandler
- Orasis Investigative Site - Mesa
- Orasis Investigative Site - Phoenix
Texas
- Orasis Investigative Site - Cedar Park
- Orasis Investigative Site - San Antonio
Utah
- Orasis Investigative Site - Clinton
- Orasis Investigative Site - Draper
Colorado
- Orasis Investigative Site - Littleton
Connecticut
- Orasis Investigative Site - Danbury
Florida
- Orasis Investigative Site - Delray Beach
Illinois
- Orasis Investigative Site - Rock Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2022-01-28 |
| Phase | Phase 3 |
What the finished NCT04599972 record still lists
NCT04599972 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, above the 263-participant average among 38 other Presbyopia trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT04599972 lists 18 locations in 11 states (California, Arizona, Texas).
Frequently Asked Questions
What is clinical trial NCT04599972 about?
NCT04599972 is a clinical study titled "An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)". 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 NCT04599972?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2020-10-26. Estimated completion is 2022-01-28.
What conditions does trial NCT04599972 study?
This clinical trial studies the following conditions: Presbyopia.
What interventions are being tested in trial NCT04599972?
The interventions under investigation include: Vehicle (DRUG), CSF-1 (DRUG).
Who is sponsoring clinical trial NCT04599972?
This trial is sponsored by Orasis Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04599972 being conducted?
This trial has 18 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Presbyopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04599972's enrollment target sits among peer trials
304 8th of 38 higher than 31 of 38 other Presbyopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Presbyopia 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.
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