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NCT04657172 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults
A Phase 3 study of Presbyopia, sponsored by Eyenovia.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
- 9
- Study locations
NCT04657172: Completed Phase 3 study of Presbyopia, sponsored by Eyenovia.
NCT04657172 is a Phase 3 study of Presbyopia that has completed, run by Eyenovia. The registered enrollment target is 84 participants, below the 268-participant average among 38 other Presbyopia trials with a reported enrollment target (69% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04657172, a Phase 3 study of Presbyopia, has completed, sponsored by Eyenovia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
- 9
- Study locations
Study Summary
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
Primary Outcome
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pilocarpine Ophthalmic
Study Locations (9)
California
- VISION-1 Study Site #21 - Azusa
- VISION-1 Study Site #52 - Newport Beach
North Carolina
- VISION-1 Study Site #17 - High Point
- VISION-1 Study Site #22 - Raleigh
Colorado
- VISION-1 Study Site #54 - Fort Collins
Florida
- VISION-1 Study Site #53 - Orlando
New York
- VISION-1 Study Site #50 - New York
Pennsylvania
- VISION-1 Study Site #51 - Cranberry Township
Texas
- VISION-1 Study Site #03 - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2021-03-26 |
| Phase | Phase 3 |
What the finished NCT04657172 record still lists
NCT04657172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 268-participant average among 38 other Presbyopia trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04657172 lists 9 locations in 7 states (California, North Carolina, Colorado).
Frequently Asked Questions
What is clinical trial NCT04657172 about?
NCT04657172 is a clinical study titled "Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults". Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are...
What is the current status of trial NCT04657172?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2020-12-15. Estimated completion is 2021-03-26.
What conditions does trial NCT04657172 study?
This clinical trial studies the following conditions: Presbyopia.
What interventions are being tested in trial NCT04657172?
The interventions under investigation include: Placebo (DRUG), Pilocarpine Ophthalmic (DRUG).
Who is sponsoring clinical trial NCT04657172?
This trial is sponsored by Eyenovia, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04657172 being conducted?
This trial has 9 study locations across California, Colorado, Florida, New York, North Carolina. 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 NCT04657172's enrollment target sits among peer trials
84 17th of 38 higher than 22 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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