MiSight 1 Day Safety Post-Approval Study

Description

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.

Conditions

Myopia

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

MiSight 1 Day Safety Post-Approval Study

MiSight 1 Day Safety Post-Approval Study

Condition
Myopia
Intervention / Treatment

-

Contacts and Locations

Gilbert

Experts on Sight LLC., Gilbert, Arizona, United States, 85297

Centerton

Centerton Family Eyecare, Centerton, Arkansas, United States, 72719

Berkeley

University of California, Berkeley University Eye Center, Berkeley, California, United States, 94720

Cupertino

Golden Vision Cupertino Optometry, Cupertino, California, United States, 95014

Danville

Boghossian Vision, Danville, California, United States, 94506

Dublin

Iron Horse Optometric Group, Dublin, California, United States, 94568

Fremont

Capitol Eye Care Center Optometry, Fremont, California, United States, 94536

Irvine

Irvine Eye Physicians and Surgeons Inc, Irvine, California, United States, 92618

Oakland

Elsa Pao OD, Inc, Oakland, California, United States, 94607

San Jose

Perfect Pair Optometry, San Jose, California, United States, 95118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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) eyeglasses.
  • 1. Acute and subacute inflammation or infection of the anterior chamber of the eye.
  • 2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
  • 3. Severe insufficiency of lacrimal secretion (dry eyes).
  • 4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
  • 5. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
  • 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
  • 7. Any active corneal infection (bacterial, fungal, or viral).
  • 8. If eyes are red or irritated.
  • 9. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
  • 10. 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.

Ages Eligible for Study

8 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Coopervision, Inc.,

William Gleason, OD, PRINCIPAL_INVESTIGATOR, Foresight Regulatory Strategies

Study Record Dates

2027-05-30