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NCT03942419 · ClinicalTrials.gov registry record · Phase 3
Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
A Phase 3 study, sponsored by Eyenovia.
- Terminated
- Registry status
- Phase 3
- Development phase
- 438
- Enrollment target
NCT03942419: Clinical Trial Phase 3 study, sponsored by Eyenovia.
NCT03942419 is a Phase 3 study that was terminated before completion, run by Eyenovia. The registered enrollment target is 438 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03942419, a Phase 3 study, was terminated before completion, sponsored by Eyenovia.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 438 participants
- Enrollment target
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.
Primary Outcome
The proportion of primary study eyes showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction.
Interventions
- DRUG Placebo Ophthalmic Solution
- DRUG Atropine 0.01% Ophthalmic Solution
- DRUG Atropine 0.1% Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2024-11-20 |
| Phase | Phase 3 |
Why NCT03942419 stopped before completion
NCT03942419 is an interventional study that assigns participants to a tested intervention. The registered 438 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Ophthalmic Solution is the first listed.
NCT03942419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03942419 about?
NCT03942419 is a clinical study titled "Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression". 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...
What is the current status of trial NCT03942419?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2019-06-03. Estimated completion is 2024-11-20.
What interventions are being tested in trial NCT03942419?
The interventions under investigation include: Placebo Ophthalmic Solution (DRUG), Atropine 0.01% Ophthalmic Solution (DRUG), Atropine 0.1% Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT03942419?
This trial is sponsored by Eyenovia, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03942419's enrollment target sits among peer trials
438 874th of 2000 higher than 1,127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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