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NCT03751631 · 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 of Mydriasis, sponsored by Eyenovia.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT03751631: Completed Phase 3 study of Mydriasis, sponsored by Eyenovia.
NCT03751631 is a Phase 3 study of Mydriasis that has completed, run by Eyenovia. The registered enrollment target is 70 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03751631, a Phase 3 study of Mydriasis, has completed, sponsored by Eyenovia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs 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.
Conditions Studied
Interventions
- DRUG Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)
- DRUG Tropicamide 1% ophthalmic solution (TR)
- DRUG Phenylephrine 2.5% ophthalmic solution (PE)
Study Locations (1)
California
- WCCT - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2019-01-11 |
| Phase | Phase 3 |
What the finished NCT03751631 record still lists
NCT03751631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Mydriasis appearing as the primary indexed condition, and to 3 interventions - of which Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) is the first listed.
NCT03751631 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03751631 about?
NCT03751631 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/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pu...
What is the current status of trial NCT03751631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2018-11-15. Estimated completion is 2019-01-11.
What conditions does trial NCT03751631 study?
This clinical trial studies the following conditions: Mydriasis.
What interventions are being tested in trial NCT03751631?
The interventions under investigation include: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) (DRUG), Tropicamide 1% ophthalmic solution (TR) (DRUG), Phenylephrine 2.5% ophthalmic solution (PE) (DRUG).
Who is sponsoring clinical trial NCT03751631?
This trial is sponsored by Eyenovia, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03751631 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03751631's enrollment target sits among peer trials
70 1785th of 2000 higher than 208 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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