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Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
NCT05134974 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05134974
The ClinicalTrials.gov registry entry for NCT05134974 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 368 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocuphire Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05134974 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05134974?
The interventions under investigation include: Phentolamine Ophthalmic Solution 0.75% (DRUG), Phentolamine Ophthalmic Solution Vehicle (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05134974?
This trial is sponsored by Ocuphire Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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