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NCT01703559 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances
A Phase 2 study, sponsored by Ocuphire Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01703559: Completed Phase 2 study, sponsored by Ocuphire Pharma.
NCT01703559 is a Phase 2 study that has completed, run by Ocuphire Pharma. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01703559, a Phase 2 study, has completed, sponsored by Ocuphire Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate
Primary Outcome
Proportion of eyes with an increase ≥ 0.3 log (2 or more patches) in mesopic contrast sensitivity with glare at one or more frequencies at 1.5, 3, 6, 12, and 18 cycles per degree, measured with the HACSS methodology (categorical analysis)
Interventions
- DRUG Phentolamine Mesylate Ophthalmic Solution 1.0%
- DRUG Phentolamine Mesylate Ophthalmic Solution 0.5%
- OTHER Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-09-09 |
| Est. Completion | 2012-04-30 |
| Phase | Phase 2 |
What the finished NCT01703559 record still lists
NCT01703559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Phentolamine Mesylate Ophthalmic Solution 1.0% is the first listed.
NCT01703559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01703559 about?
NCT01703559 is a clinical study titled "The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances". The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% oph...
What is the current status of trial NCT01703559?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2011-09-09. Estimated completion is 2012-04-30.
What interventions are being tested in trial NCT01703559?
The interventions under investigation include: Phentolamine Mesylate Ophthalmic Solution 1.0% (DRUG), Phentolamine Mesylate Ophthalmic Solution 0.5% (DRUG), Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (OTHER).
Who is sponsoring clinical trial NCT01703559?
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 NCT01703559's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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