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NCT04620213 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
A Phase 3 study, sponsored by Ocuphire Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
NCT04620213: Completed Phase 3 study, sponsored by Ocuphire Pharma.
NCT04620213 is a Phase 3 study that has completed, run by Ocuphire Pharma. The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04620213, a Phase 3 study, has completed, sponsored by Ocuphire Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
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
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%
- OTHER Phentolamine Ophthalmic Solution Vehicle (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2021-03-15 |
| Phase | Phase 3 |
What the finished NCT04620213 record still lists
NCT04620213 is an interventional study that assigns participants to a tested intervention. The registered 185 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Phentolamine Ophthalmic Solution 0.75% is the first listed.
NCT04620213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04620213 about?
NCT04620213 is a clinical study titled "Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis". 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 NCT04620213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2020-11-18. Estimated completion is 2021-03-15.
What interventions are being tested in trial NCT04620213?
The interventions under investigation include: Phentolamine Ophthalmic Solution 0.75% (DRUG), Phentolamine Ophthalmic Solution Vehicle (Placebo) (OTHER).
Who is sponsoring clinical trial NCT04620213?
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 NCT04620213's enrollment target sits among peer trials
185 1417th of 2000 higher than 583 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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