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NCT03751098 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
A Phase 3 study, sponsored by Eyenovia.
- Completed
- Registry status
- Phase 3
- Development phase
- 76
- Enrollment target
NCT03751098: Completed Phase 3 study, sponsored by Eyenovia.
NCT03751098 is a Phase 3 study that has completed, run by Eyenovia. The registered enrollment target is 76 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03751098, a Phase 3 study, has completed, sponsored by Eyenovia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 76 participants
- Enrollment target
Study Summary
This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit, after baseline measurements, either the study drug or placebo was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.
Primary Outcome
Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome.
Interventions
- DRUG Placebo
- DRUG Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2018-12-01 |
| Est. Completion | 2019-01-21 |
| Phase | Phase 3 |
What the finished NCT03751098 record still lists
NCT03751098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03751098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03751098 about?
NCT03751098 is a clinical study titled "Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation". This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit, after baseline measurements, either the study drug or placebo was administered to both eyes, then pupil dilation and safety asse...
What is the current status of trial NCT03751098?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 76 participants. The study started on 2018-12-01. Estimated completion is 2019-01-21.
What interventions are being tested in trial NCT03751098?
The interventions under investigation include: Placebo (DRUG), Tropicamide/Phenylephrine ophthalmic solution (TR/PE) (DRUG).
Who is sponsoring clinical trial NCT03751098?
This trial is sponsored by Eyenovia, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03751098's enrollment target sits among peer trials
76 1773rd of 2000 higher than 228 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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