MiSight 1 Day Safety Post-Approval Study
NCT05285527 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400
Last updated 2025-08-14
Summary
The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.
Conditions
- Myopia
Interventions
- DEVICE
-
MiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.
Sponsors & Collaborators
-
CooperVision, Inc.
lead INDUSTRY
Principal Investigators
-
William Gleason, OD · Foresight Regulatory Strategies
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-08-15
- Primary Completion
- 2027-04-30
- Completion
- 2027-05-30
- FDA Device
- Yes
Countries
- United States
- Canada
Study Locations
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