What is MiSight 1 Day studying for myopia?

MiSight 1 Day lenses are being studied to confirm their safety for daily use in children with myopia. This trial evaluates how well these lenses perform in the intended patient group over three years. CooperVision, Inc. sponsors the research to ensure safe use in young lens wearers.

Who may be eligible for this myopia clinical trial?

Children aged 8 to 12 years with myopia who have good vision corrected to at least 20/25 and no eye disease may be eligible. Both boys and girls can participate. Other factors include ability to wear lenses about 10 hours daily and parent consent. Please review eligibility criteria for more details.

Is there any cost to participate in this myopia clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, participants may have personal travel expenses that vary and are not guaranteed to be covered. This can include transportation to and from study visits.

Actively Recruiting

Phase Not Applicable

Age: 8Years - 12Years

All Genders

Healthy Volunteers

ID05285527

MiSight 1 Day Safety Post-Approval Study for Children with Myopia

Led by CooperVision, Inc. · Updated on 2025-08-14

2400

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to confirm the safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. It is a prospective post-approval study conducted in the US, evaluating how these lenses perform within the intended patient population. Safety data from a related study will also be used to supplement the findings. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on monitoring the incidence of microbial keratitis and other types of infiltrative keratitis, as well as any loss of best-corrected visual acuity. The study does not include a comparison group or masking. Throughout the study, participants will be regularly assessed for eye health and vision changes. Researchers will collect and review data on eye infections and visual acuity loss over the three-year period. Parents or guardians will provide consent and assist with data release related to healthcare encounters. The total participation time is three years with ongoing safety monitoring.

CONDITIONS

Brief Title

MiSight 1 Day Safety Post-Approval Study

Who Can Participate

Age: 8Years - 12Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Be between 8 and 12 years of age inclusive at the time of enrollment
Manifest Refraction - Spherical Equivalent Refractive Error (SERE) between -0.50 D and -7.00 D inclusive at baseline
Best-corrected visual acuity of at least 20/25 in both eyes
Free of ocular disease or abnormalities, including corneal scars
Parent or guardian can understand the study and consent to use of child's de-identified health data
Parent or guardian must sign release of medical records related to study outcomes
Interested in wearing contact lenses about 10 hours per day, 6 days per week
Has or will obtain wearable eyeglasses with 20/40 vision or better prior to lens dispensing

You will not qualify if you...

Acute or subacute inflammation or infection of the front eye chamber
Any eye disease, injury, or abnormality affecting cornea, conjunctiva, or eyelids
Severe dry eyes (lacrimal secretion insufficiency)
Reduced corneal sensitivity (corneal hypoesthesia), unless aphakic
Any systemic disease affecting the eye or worsened by contact lens wear
Allergic reactions to contact lenses or lens solutions
Active corneal infection of bacterial, fungal, or viral origin
Red or irritated eyes
Inability to follow lens care or wear routine, or unable to get help with it
Use of medication that interferes with contact lens wear or myopia control

Research Team

Kathryn Richdale, OD, PhD

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