NCT05285527

MiSight 1 Day Safety Post-Approval Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (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 safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.

Detailed description

This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	MiSight 1 Day	Subjects will wear MiSight 1 day lenses for three years.

Timeline

• Start date: 2022-08-15
• Primary completion: 2027-04-30
• Completion: 2027-05-30
• First posted: 2022-03-17
• Last updated: 2025-08-14

Locations

50 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study