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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 is a Phase 3 study that has completed, run by Eyenovia. The registered enrollment target is 76 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03751098
The ClinicalTrials.gov registry entry for NCT03751098 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 76 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03751098 reports 0 study locations.
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.
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