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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 is a Phase 3 study of Mydriasis that has completed, run by Eyenovia. The registered enrollment target is 70 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03751631
The ClinicalTrials.gov registry entry for NCT03751631 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eyenovia, which has 7 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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