MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
- Conditions
- Myopia
- Interventions
- Device: Proclear 1 dayDevice: MiSight 1 Day
- Registration Number
- NCT05285553
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.
- Detailed Description
This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years.
Part 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses.
Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- Informed Consent and Assent have been completed
- Be between 8 and 12 years of age inclusive at the time of enrollment.
- Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye
- Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
- Anisometropia: ≤ 1.50D SERE.
- Astigmatism: ≤ 0.75 D
- Free of ocular disease or abnormalities (including any corneal scar)
- Currently have good general health.
- Agree to accept the lens as assigned by the randomization.
- Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
- Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes.
- Able to maintain the visit schedule.
- Willingness to participate in the trial for 4 years.
- 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.
-
Current or prior use of any pharmaceuticals or other methods for control of myopia, such as bifocals, progressive addition lenses, orthokeratology, atropine, pirenzepine or any other myopia control treatment.
-
Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day.
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Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
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Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:
- 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.
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Has history of:
- Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
- Giant papillary conjunctivitis
- Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses
- A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
- Corneal hypoesthesia (reduced corneal sensitivity)
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Keratoconus or an irregular cornea.
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Strabismus or amblyopia.
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Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proclear 1 day Proclear 1 day Proclear 1 day MiSight 1 day MiSight 1 Day MiSight 1 day
- Primary Outcome Measures
Name Time Method Mean difference in cycloplegic SERE change from baseline 3 years Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters
Mean difference in axial length change from baseline 3 years Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters
Mean difference in rate of cycloplegic SERE change - Part 2 study 1 year Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment; measured with cycloplegic auto-refraction in Diopters
Mean difference in rate of axial length - Part 2 study 1 year Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment.
- Secondary Outcome Measures
Name Time Method Percentage of subjects with no appreciable myopic progression 3 years Percentage of subjects with no appreciable myopic progression (-0.25D change or less)
Visual symptoms and the effects on activities of daily living 3 years Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure
Trial Locations
- Locations (30)
Nova Southeastern University (NSU) College of Optometry
🇺🇸Fort Lauderdale, Florida, United States
Chicago College of Optometry
🇺🇸Downers Grove, Illinois, United States
Utah Eye Centers
🇺🇸Ogden, Utah, United States
University of Alabama School of Optometry
🇺🇸Birmingham, Alabama, United States
Marshall B. Ketchum University Southern California College of Optometry
🇺🇸Fullerton, California, United States
Vision Solutions Optometry Inc
🇺🇸La Mesa, California, United States
Paje Optometric
🇺🇸Santa Ana, California, United States
Coan Eye Care and Optical Boutique
🇺🇸Ocoee, Florida, United States
West Broward Eyecare Associates
🇺🇸Tamarac, Florida, United States
Bright Eyes Family Vision Care
🇺🇸Tampa, Florida, United States
SoLo Eye Care & Eyewear Gallery
🇺🇸Chicago, Illinois, United States
Illinois College of Optometry
🇺🇸Chicago, Illinois, United States
Carillon Vision Care
🇺🇸Glenview, Illinois, United States
Brain Vision Institute
🇺🇸Schaumburg, Illinois, United States
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
New England College of Optometry
🇺🇸Boston, Massachusetts, United States
Cornea and Contact Lens Institute
🇺🇸Edina, Minnesota, United States
Vision Source EyeCare
🇺🇸Kansas City, Missouri, United States
Athens Eye Care
🇺🇸Athens, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
ProCare Vision Center, Inc.
🇺🇸Granville, Ohio, United States
Miamisburg Vision Care
🇺🇸Miamisburg, Ohio, United States
Eye Care Professionals
🇺🇸Powell, Ohio, United States
Southern College of Optometry
🇺🇸Memphis, Tennessee, United States
Texas State Optical
🇺🇸Beaumont, Texas, United States
University of Houston College of Optometry
🇺🇸Houston, Texas, United States
Vision One Eyecare
🇺🇸Katy, Texas, United States
Lone Star Vision
🇺🇸Plano, Texas, United States
Virginia Pediatric Eye Care
🇺🇸Chesapeake, Virginia, United States
Factoria Eye Clinic
🇺🇸Bellevue, Washington, United States