MiSight 1 Day Safety Post-Approval Study
- Conditions
- Myopia
- Interventions
- Device: MiSight 1 Day
- Registration Number
- NCT05285527
- Lead Sponsor
- Coopervision, Inc.
- 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.
- Detailed Description
This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2400
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MiSight 1 Day MiSight 1 Day MiSight 1 Day
- Primary Outcome Measures
Name Time Method Incidence of Microbial Keratitis (MK) 3 years Incidence of Microbial Keratitis (MK) ≥ 1 mm
- Secondary Outcome Measures
Name Time Method Incidence of peripheral infiltrative keratitis/non-infectious ulcers 3 years Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm
Incidence of non-infectious infiltrative keratitis 3 years Incidence of non-infectious infiltrative keratitis ≤ 1 mm
Incidence of loss of best-corrected visual acuity 3 years Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event.
Trial Locations
- Locations (47)
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
Wellesley Vision Group at Optical Design
🇺🇸Wellesley, Massachusetts, United States
Missouri Eye Consultants - California
🇺🇸California, Missouri, United States
Center for Vision and Learning
🇺🇸Des Peres, Missouri, United States
Advocare Pediatric Eye Physicians
🇺🇸Morristown, New Jersey, United States
Clarity Vision
🇺🇸Apex, North Carolina, United States
Cary Family Eye Care
🇺🇸Cary, North Carolina, United States
Chagrin Valley Optometrists, Inc.
🇺🇸Chagrin Falls, Ohio, United States
Pickerington Eye Care
🇺🇸Pickerington, Ohio, United States
Nittany Eye Associates, LLC
🇺🇸State College, Pennsylvania, United States
Texas State Optical
🇺🇸Beaumont, Texas, United States
Bellaire Family Eye Care
🇺🇸Bellaire, Texas, United States
Clarkson EyeCare KIDS
🇺🇸Frisco, Texas, United States
Lone Star Vision Center
🇺🇸Plano, Texas, United States
Stone Oak Vision Source
🇺🇸San Antonio, Texas, United States
Child & Family Eye Care Center
🇺🇸Pleasant Grove, Utah, United States
Broadway Eye Clinic
🇺🇸Salt Lake City, Utah, United States
Invision Eye Health
🇺🇸Sandy, Utah, United States
Colonial Eye Care
🇺🇸Williamsburg, Virginia, United States
Redmond Eye Clinic
🇺🇸Redmond, Washington, United States
University of California, Berkeley University Eye Center
🇺🇸Berkeley, California, United States
Golden Vision Cupertino Optometry
🇺🇸Cupertino, California, United States
Bronx Eye Associates
🇺🇸Bronx, New York, United States
Drs. McIntyre, Garza, Avila and Jurica, Optometrists
🇺🇸Corpus Christi, Texas, United States
Experts on Sight LLC.
🇺🇸Gilbert, Arizona, United States
Centerton Family Eyecare
🇺🇸Centerton, Arkansas, 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
Spectrum Optical, PLLC
🇺🇸Morgantown, West Virginia, United States