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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: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT03334253 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calcula
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 |
What the finished NCT03334253 record still lists
NCT03334253 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Atropine is the first listed.
NCT03334253 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03334253's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 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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