drugset
drugset / Trial / NCT03751631

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

NCT03751631 ↗

Phase 3 Completed 70 enrolled Eyenovia Inc.
RandomizedCrossoverDouble-blindDiagnostic

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.

Timeline

Start
2018-11-15
Primary completion
2019-01-11
Completion
2019-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylephrine Small molecule 2.5 % Other
Subject Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) Unknown 1 % Other
Subject Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) Unknown 2.5 % Other
Subject tropicamide Small molecule 1 % Other

Indications

No indication recorded.