Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
Public ClinicalTrials.gov record NCT04620213. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Healthy Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04620213
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 185 participants
Conditions and interventions
Interventions
- Phentolamine Ophthalmic Solution 0.75% Drug
- Phentolamine Ophthalmic Solution Vehicle (Placebo) Other
Drug · Other
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2020 (Actual)
- Primary completion
- Dec 23, 2020 (Actual)
- Completion
- Mar 15, 2021 (Actual)
- Last update posted
- Sep 11, 2023
2020 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site 11 | Newport Beach | California | 92663 | — |
| Clinical Site 10 | San Diego | California | 92123 | — |
| Clinical Site 9 | Longwood | Florida | 32779 | — |
| Clinical Site 6 | Orlando | Florida | 32751 | — |
| Clinical Site 2 | Roswell | Georgia | 30075 | — |
| Clinical Site 7 | Pittsburg | Kansas | 66762 | — |
| Clinical Site 3 | Shawnee Mission | Kansas | 66203 | — |
| Clinical Site 5 | Athens | Ohio | 45701 | — |
| Clinical Site 12 | Cincinnati | Ohio | 45242 | — |
| Clinical Site 1 | Cleveland | Ohio | 44195 | — |
| Clinical Site 8 | Warwick | Rhode Island | 02888 | — |
| Clinical Site 4 | Memphis | Tennessee | 38119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04620213, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 11, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04620213 live on ClinicalTrials.gov.