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NCT03334253 · ClinicalTrials.gov registry record · Phase 3
Low-Dose Atropine for Treatment of Myopia
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT03334253 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 200 participants.
The verdict
NCT03334253, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Interventions
- DRUG Atropine
- OTHER Placebo Eyedrops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2022-09-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03334253
The ClinicalTrials.gov registry entry for NCT03334253 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atropine is the first listed.
NCT03334253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03334253 about?
NCT03334253 is a clinical study titled "Low-Dose Atropine for Treatment of Myopia". Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. To determine the efficacy of at...
What is the current status of trial NCT03334253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2018-06-01. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT03334253?
The interventions under investigation include: Atropine (DRUG), Placebo Eyedrops (OTHER).
Who is sponsoring clinical trial NCT03334253?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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