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Recruiting NCT05285527

MiSight 1 Day Safety Post-Approval Study

Trial Parameters

Condition Myopia
Sponsor CooperVision, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 2,400
Sex ALL
Min Age 8 Years
Max Age 12 Years
Start Date 2022-08-15
Completion 2027-04-30
Interventions
MiSight 1 Day

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Be between 8 and 12 years of age inclusive at the time of enrollment. 2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane). 3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally 4. Free of ocular disease or abnormalities (including any corneal scar) 5. The parent/guardian must be capable of comprehending the nature of the study and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this study. Assent will be obtained from the child in a manner specified by the IRB. 6. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data. 7. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week. 8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better

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