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NCT05223478 · ClinicalTrials.gov registry record · Phase 3
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
A Phase 3 study, sponsored by Ocuphire Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT05223478 is a Phase 3 study that has completed, run by Ocuphire Pharma. The registered enrollment target is 23 participants.
The verdict
NCT05223478, a Phase 3 study, has completed, sponsored by Ocuphire Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
The objectives of this study are: * To evaluate the safety of Nyxol in pediatric subjects * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."
Interventions
- DRUG Phentolamine Ophthalmic Solution 0.75%
- DRUG Phentolamine Ophthalmic Solution Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2022-04-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05223478
The ClinicalTrials.gov registry entry for NCT05223478 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 23 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.
NCT05223478 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05223478 about?
NCT05223478 is a clinical study titled "Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects". The objectives of this study are: * To evaluate the safety of Nyxol in pediatric subjects * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to...
What is the current status of trial NCT05223478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2021-12-17. Estimated completion is 2022-04-28.
What interventions are being tested in trial NCT05223478?
The interventions under investigation include: Phentolamine Ophthalmic Solution 0.75% (DRUG), Phentolamine Ophthalmic Solution Vehicle (DRUG).
Who is sponsoring clinical trial NCT05223478?
This trial is sponsored by Ocuphire Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
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