CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) +2 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/NCT03751631
NCT03751631Phase 3Completed
CompareCT.gov

A Double-Masked, Active-Controlled Study of the Safety and Efficacy of 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 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Tropicamide 1% ophthalmic solution (TR), and 1 other intervention for Mydriasis. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 23, 2018
Enrollment StartNov 15, 2018
Primary CompletionJan 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.6 years ago

Interventions

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)drug

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)drug

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)drug

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser