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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 is a Phase 3 study that was terminated before completion, run by Eyenovia. The registered enrollment target is 438 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03942419
The ClinicalTrials.gov registry entry for NCT03942419 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eyenovia, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Ophthalmic Solution is the first listed.
NCT03942419 reports 0 study locations.
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.
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