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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 is a Phase 3 study that has completed, run by Ocuphire Pharma. The registered enrollment target is 185 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04620213
The ClinicalTrials.gov registry entry for NCT04620213 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocuphire Pharma, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Phentolamine Ophthalmic Solution 0.75% is the first listed.
NCT04620213 reports 0 study locations.
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.
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