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NCT07095894 · ClinicalTrials.gov registry record · Phase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
NCT07095894 is a Phase 3 study that is actively recruiting participants, run by Jaeb Center for Health Research. The registered enrollment target is 348 participants.
The verdict
NCT07095894, a Phase 3 study, is actively recruiting participants, sponsored by Jaeb Center for Health Research.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
Study Summary
To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth. After a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to \<12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively. All children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months). The study is funded by the National Eye Institute, part of the NIH, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of Spectacle lenses with H.A.L.T.\* MAX technology, is providing the eyeglasses and financial support for the study. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.
Interventions
- DRUG Atropine
- DEVICE Spectacles with HAL
- DRUG Placebo Eyedrops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2029-06-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07095894
The ClinicalTrials.gov registry entry for NCT07095894 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 348 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 3 interventions - of which Atropine is the first listed.
NCT07095894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07095894 about?
NCT07095894 is a clinical study titled "A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control". To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promisi...
What is the current status of trial NCT07095894?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2026-06-01. Estimated completion is 2029-06-01.
What interventions are being tested in trial NCT07095894?
The interventions under investigation include: Atropine (DRUG), Spectacles with HAL (DEVICE), Placebo Eyedrops (DRUG).
Who is sponsoring clinical trial NCT07095894?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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