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NCT01848041 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis
A Phase 1 study, sponsored by RVL Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT01848041: Completed Phase 1 study, sponsored by RVL Pharmaceuticals.
NCT01848041 is a Phase 1 study that has completed, run by RVL Pharmaceuticals. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01848041, a Phase 1 study, has completed, sponsored by RVL Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.
Primary Outcome
The mean change from baseline (Day 0, Hour 0) in number of points seen on the HVF 36-point ptosis protocol test according to a pre-planned hierarchical analysis as follows: 1. Hour 6 on Visit 4 (Day 13) for the BID regimen versus vehicle 2. Hour 6 on Visit 4 (Day 13) for the QD regimen versus vehicle 3. Hour 2 on Visit 4 (Day 13) for the BID regimen versus vehicle 4. Hour 2 on Visit 4 (Day 13) for the QD regimen versus vehicle Testing was performed using a Humphrey perimeter at a grid of 36 po
Interventions
- DRUG RVL-1201
- DRUG RVL-1201 Vehicle Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
What the finished NCT01848041 record still lists
NCT01848041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which RVL-1201 is the first listed.
NCT01848041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01848041 about?
NCT01848041 is a clinical study titled "Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis". This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.
What is the current status of trial NCT01848041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-05. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01848041?
The interventions under investigation include: RVL-1201 (DRUG), RVL-1201 Vehicle Placebo (DRUG).
Who is sponsoring clinical trial NCT01848041?
This trial is sponsored by RVL Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01848041's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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