CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 76 enrolled
Drug / intervention
Tropicamide/Phenylephrine ophthalmic solution (TR/PE) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03751098
NCT03751098Phase 3Completed
CompareCT.gov

A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

Eyenovia Inc.·interventional·Posted Nov 23, 2018·Updated Mar 18, 2022

In Brief

A Phase 3 clinical trial evaluating Tropicamide/Phenylephrine ophthalmic solution (TR/PE) and Placebo for Mydriasis. Completed, enrolled 76 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMydriasis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 23, 2018
Enrollment StartDec 1, 2018
Primary CompletionJan 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.6 years ago

Interventions

Tropicamide/Phenylephrine ophthalmic solution (TR/PE)drug

Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Placebodrug

Eyewash administered with the Optejet microdose dispenser