MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
CooperVision, Inc.
Summary
The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.
Description
This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years. Part 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses. Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.
Eligibility
- Age range
- 8–12 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Informed Consent and Assent have been completed 2. Be between 8 and 12 years of age inclusive at the time of enrollment. 3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye 4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye. 5. Anisometropia: ≤ 1.50D SERE. 6. Astigmatism: ≤ 0.75 D 7. Free of ocular disease or abnormalities (including any corneal scar) 8. Currently have good general health. 9. Agree to…
Interventions
- DeviceMiSight 1 Day
Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
- DeviceProclear 1 day
Part 1 of the study - subjects will be randomized to wear Proclear 1 day for three years. Part 2 of the study - All the subjects will wear Proclear 1 day lenses for one year.
Locations (30)
- University of Alabama School of OptometryBirmingham, Alabama
- Marshall B. Ketchum University Southern California College of OptometryFullerton, California
- Vision Solutions Optometry IncLa Mesa, California
- Paje OptometricSanta Ana, California
- Coan Eye Care and Optical BoutiqueOcoee, Florida
- West Broward Eyecare AssociatesTamarac, Florida