drugset / Trial / NCT03751098

Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation

NCT03751098 ↗

Phase 3 Completed 76 enrolled Eyenovia Inc.
RandomizedCrossoverDouble-blindDiagnostic

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.

Timeline

Start
2018-12-01
Primary completion
2019-01-21
Completion
2019-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Tropicamide/Phenylephrine Unknown 1 % Other
Subject Tropicamide/Phenylephrine Unknown 2.5 % Other

Indications

No indication recorded.