Trials / Completed
CompletedNCT04126057
Myopia Assessment of Two Manufacturing Processes
Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- SightGlass Vision, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Accepted
Summary
Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SightGlass Vision DOT Spectacle Lenses | Subjects randomized to test vs control, left eyes and right eyes |
Timeline
- Start date
- 2019-12-02
- Primary completion
- 2020-09-15
- Completion
- 2020-09-16
- First posted
- 2019-10-14
- Last updated
- 2022-01-25
- Results posted
- 2022-01-25
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04126057. Inclusion in this directory is not an endorsement.