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

NCT03751098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-03-18

Study results available
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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.

Conditions

  • Mydriasis

Interventions

DRUG

Tropicamide/Phenylephrine ophthalmic solution (TR/PE)

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

DRUG

Placebo

Eyewash administered with the Optejet microdose dispenser

Sponsors & Collaborators

  • Eyenovia Inc.

    lead INDUSTRY

Principal Investigators

  • Tsontcho Ianchulev, MD, MPH · Eyenovia Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-01-21
Completion
2019-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03751098 on ClinicalTrials.gov