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NCT05134974 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
A Phase 3 study of Mydriasis and Dilation, sponsored by Ocuphire Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 368
- Enrollment target
- 15
- Study locations
NCT05134974: Completed Phase 3 study of Mydriasis and Dilation, sponsored by Ocuphire Pharma.
NCT05134974 is a Phase 3 study of Mydriasis and Dilation that has completed, run by Ocuphire Pharma. The registered enrollment target is 368 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05134974, a Phase 3 study of Mydriasis and Dilation, has completed, sponsored by Ocuphire Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 368 participants
- Enrollment target
- 15
- Study locations
Study Summary
The objectives of this study are: * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine * To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd) * To evaluate the safety of Nyxol * To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis * To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling
Primary Outcome
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
Interventions
- DRUG Phentolamine Ophthalmic Solution 0.75%
- DRUG Phentolamine Ophthalmic Solution Vehicle
Study Locations (15)
California
- Clinical Site 10 - Newport Beach
- Clinical Site 12 - Westminster
Florida
- Clinical Site 9 - Delray Beach
- Clinical Site 8 - Longwood
Georgia
- Clinical Site 6 - Morrow
- Clinical Site 1 - Roswell
Illinois
- Clinical Site 13 - Lake Villa
Kansas
- Clinical Site 5 - Pittsburg
Minnesota
- Clinical Site 2 - Bloomington
North Carolina
- Clinical Site 15 - Garner
Ohio
- Clinical Site 4 - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2022-03-29 |
| Phase | Phase 3 |
What the finished NCT05134974 record still lists
NCT05134974 is an interventional study that assigns participants to a tested intervention. The registered 368 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 (52% lower).
The record links to 2 conditions, with Mydriasis appearing as the primary indexed condition, and to 2 interventions - of which Phentolamine Ophthalmic Solution 0.75% is the first listed.
NCT05134974 lists 15 locations in 12 states (California, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT05134974 about?
NCT05134974 is a clinical study titled "Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)". The objectives of this study are: * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine * To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (...
What is the current status of trial NCT05134974?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 368 participants. The study started on 2021-11-18. Estimated completion is 2022-03-29.
What conditions does trial NCT05134974 study?
This clinical trial studies the following conditions: Mydriasis, Dilation.
What interventions are being tested in trial NCT05134974?
The interventions under investigation include: Phentolamine Ophthalmic Solution 0.75% (DRUG), Phentolamine Ophthalmic Solution Vehicle (DRUG).
Who is sponsoring clinical trial NCT05134974?
This trial is sponsored by Ocuphire Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05134974 being conducted?
This trial has 15 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05134974's enrollment target sits among peer trials
368 996th of 2000 higher than 1,003 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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