RECRUITING
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MiSight 1 Day Safety Post-Approval Study
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
🗓️ Study Start (Actual) 15 August 2022
🗓️ Primary Completion (Estimated) 30 April 2027
✅ Study Completion (Estimated) 30 May 2027
👥 Enrollment (Estimated) 2400
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Gilbert, Arizona, United States
📍 Centerton, Arkansas, United States
📍 Cupertino, California, United States
📍 Danville, California, United States
📍 Dublin, California, United States
📍 Fremont, California, United States
📍 Irvine, California, United States
📍 Milpitas, California, United States
📍 Oakland, California, United States
📍 San Jose, California, United States
📍 San Jose, California, United States
📍 Centennial, Colorado, United States
📍 Milford, Connecticut, United States
📍 Lake Worth, Florida, United States
📍 Miami, Florida, United States
📍 Oviedo, Florida, United States
📍 Saint Johns, Florida, United States
📍 Sarasota, Florida, United States
📍 Weston, Florida, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Darien, Illinois, United States
📍 Glenview, Illinois, United States
📍 Carmel, Indiana, United States
📍 Rockville, Maryland, United States
📍 Wellesley, Massachusetts, United States
📍 California, Missouri, United States
📍 Des Peres, Missouri, United States
📍 Morristown, New Jersey, United States
📍 Bronx, New York, United States
📍 Apex, North Carolina, United States
📍 Cary, North Carolina, United States
📍 Chagrin Falls, Ohio, United States
📍 Pickerington, Ohio, United States
📍 State College, Pennsylvania, United States
📍 Beaumont, Texas, United States
📍 Bellaire, Texas, United States
📍 Frisco, Texas, United States
📍 Plano, Texas, United States
📍 San Antonio, Texas, United States
📍 Pleasant Grove, Utah, United States
📍 Salt Lake City, Utah, United States
📍 Sandy, Utah, United States
📍 Williamsburg, Virginia, United States
📍 Redmond, Washington, United States
📍 Morgantown, West Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    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 -0.75 D and -4.00 D inclusive (at the corneal plane).
    • 3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
    • 4. Anisometropia: ≤ 1.50D SERE.
    • 5. Astigmatism: ≤ -0.75 D
    • 6. Free of ocular disease or abnormalities (including any corneal scar)
    • 7. 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.
    • 8. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
    • 9. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
    • 10. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

    Exclusion Criteria:

    • 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 (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 March 2022
  • First Submitted that Met QC Criteria 9 March 2022
  • First Posted 17 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 July 2024
  • Last Update Posted 17 July 2024
  • Last Verified July 2024
I'm interested ...!!