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NCT05646719 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
A Phase 3 study, sponsored by Ocuphire Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 333
- Enrollment target
NCT05646719: Completed Phase 3 study, sponsored by Ocuphire Pharma.
NCT05646719 is a Phase 3 study that has completed, run by Ocuphire Pharma. The registered enrollment target is 333 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05646719, a Phase 3 study, has completed, sponsored by Ocuphire Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 333 participants
- Enrollment target
Study Summary
The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.
Primary Outcome
The primary efficacy endpoint is the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with \< 5 letters of loss in photopic binocular BCDVA from Baseline at 30 min post-LDP/vehicle comparing subjects treated with Nyxol + LDP to subjects treated with placebo + LDP vehicle at Visit 5 (Stage 2 Day 8).
Interventions
- OTHER Placebo
- DRUG Phentolamine Opthalmic Solution 0.75%
- DRUG Low dose pilocarpine
- OTHER Low dose pilocarpine vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2022-12-22 |
| Est. Completion | 2023-10-11 |
| Phase | Phase 3 |
What the finished NCT05646719 record still lists
NCT05646719 is an interventional study that assigns participants to a tested intervention. The registered 333 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 (57% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05646719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05646719 about?
NCT05646719 is a clinical study titled "Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia". The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.
What is the current status of trial NCT05646719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 333 participants. The study started on 2022-12-22. Estimated completion is 2023-10-11.
What interventions are being tested in trial NCT05646719?
The interventions under investigation include: Placebo (OTHER), Phentolamine Opthalmic Solution 0.75% (DRUG), Low dose pilocarpine (DRUG), Low dose pilocarpine vehicle (OTHER).
Who is sponsoring clinical trial NCT05646719?
This trial is sponsored by Ocuphire Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05646719's enrollment target sits among peer trials
333 1061st of 2000 higher than 940 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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