MiSight 1 Day Safety Post-Approval Study

Running, not enrolling · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT05285527

Run by

CooperVision, Inc.

People needed

2400

Starts

2022-08-15

Expected to finish

2030-06-30

Last updated by the study team

2026-07-08

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be between 8 and 12 years of age inclusive at the time of enrollment.
• Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
• Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
• Free of ocular disease or abnormalities (including any corneal scar)
• 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.
• Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
• Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
• Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

You may not qualify if…

• Acute and subacute inflammation or infection of the anterior chamber of the eye.
• Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
• Severe insufficiency of lacrimal secretion (dry eyes).
• Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
• Any active corneal infection (bacterial, fungal, or viral).
• If eyes are red or irritated.
• The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
• In addition to the labeling contraindications, children who are under medication that would interfere with contact lens wear, or who are using any pharmaceuticals for control of myopia will not be included in the study.

Where it is running

• Experts on Sight LLC. — Gilbert, Arizona, United States
• Centerton Family Eyecare — Centerton, Arkansas, United States
• University of California, Berkeley University Eye Center — Berkeley, California, United States
• Golden Vision Cupertino Optometry — Cupertino, California, United States
• Boghossian Vision — Danville, California, United States
• Iron Horse Optometric Group — Dublin, California, United States
• Capitol Eye Care Center Optometry — Fremont, California, United States
• Irvine Eye Physicians and Surgeons Inc — Irvine, California, United States
• Elsa Pao OD, Inc — Oakland, California, United States
• Perfect Pair Optometry — San Jose, California, United States
• Almaden Family Optometric Center — San Jose, California, United States
• Children's Eye Physicians — Centennial, Colorado, United States
• Eye Physicians & Surgeons, PC — Milford, Connecticut, United States
• Planet Vision Eyecare — Lake Worth, Florida, United States
• Marino Eye Care — Miami, Florida, United States
• Vision Source Oviedo, INC — Oviedo, Florida, United States
• Gulf Coast Eye Center — Sarasota, Florida, United States
• Dau Family Eye Care — St. Johns, Florida, United States
• Weston Contact Lens Institute LLC — Weston, Florida, United States
• Lurie Childrens — Chicago, Illinois, United States
• Lyons Family Eye Care P.C. — Chicago, Illinois, United States
• Darien Eye Specialists — Darien, Illinois, United States
• Carillon Vision Care — Glenview, Illinois, United States
• Little Eyes Pediatric Eye Care — Carmel, Indiana, United States
• All Eyes on Rockville — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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