NCT05285553

MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	MiSight 1 Day	Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
DEVICE	Proclear 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.

Timeline

• Start date: 2022-06-25
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2022-03-17
• Last updated: 2025-08-17

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated device study