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NCT04638660 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
A Phase 3 study, sponsored by Ocuphire Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
NCT04638660: Completed Phase 3 study, sponsored by Ocuphire Pharma.
NCT04638660 is a Phase 3 study that has completed, run by Ocuphire Pharma. The registered enrollment target is 144 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04638660, a Phase 3 study, has completed, sponsored by Ocuphire Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
Study Summary
The objectives of this study are: * To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD) * To evaluate efficacy of Nyxol to improve visual performance * To evaluate the safety of Nyxol
Primary Outcome
Percent of subjects with ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (≥3 lines) of improvement in the study eye compared to baseline in monocular mLCVA at Day 8
Interventions
- DRUG Phentolamine Ophthalmic Solution 0.75%
- DRUG Phentolamine Ophthalmic Solution Vehicle (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2022-05-19 |
| Phase | Phase 3 |
What the finished NCT04638660 record still lists
NCT04638660 is an interventional study that assigns participants to a tested intervention. The registered 144 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 (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Phentolamine Ophthalmic Solution 0.75% is the first listed.
NCT04638660 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04638660 about?
NCT04638660 is a clinical study titled "Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances". The objectives of this study are: * To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD) * To evaluate efficacy of Nyxol to improve visual performance * To evaluate the safety of Nyxol
What is the current status of trial NCT04638660?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2020-12-30. Estimated completion is 2022-05-19.
What interventions are being tested in trial NCT04638660?
The interventions under investigation include: Phentolamine Ophthalmic Solution 0.75% (DRUG), Phentolamine Ophthalmic Solution Vehicle (Placebo) (DRUG).
Who is sponsoring clinical trial NCT04638660?
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 NCT04638660's enrollment target sits among peer trials
144 1559th of 2000 higher than 442 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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