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Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression

NCT03942419 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2025-01-06

No results posted yet for this study

Summary

This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.

Conditions

  • Myopia

Interventions

DRUG

Atropine 0.1% Ophthalmic Solution

Atropine 0.1% ophthalmic solution administered with a microdose dispenser

DRUG

Atropine 0.01% Ophthalmic Solution

Atropine 0.01% ophthalmic solution administered with a microdose dispenser

DRUG

Placebo Ophthalmic Solution

Placebo ophthalmic solution administered with a microdose dispenser

Sponsors & Collaborators

  • Eyenovia Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2024-10-31
Completion
2024-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03942419 on ClinicalTrials.gov