MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
NCT ID: NCT05285553
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2022-06-25
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MiSight 1 day
MiSight 1 day
MiSight 1 Day
Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
Proclear 1 day
Proclear 1 day
Proclear 1 day
Part 1 of the study - subjects will be randomized to wear Proclear 1 day for three years.
Part 2 of the study - All the subjects will wear Proclear 1 day lenses for one year.
Interventions
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MiSight 1 Day
Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
Proclear 1 day
Part 1 of the study - subjects will be randomized to wear Proclear 1 day for three years.
Part 2 of the study - All the subjects will wear Proclear 1 day lenses for one year.
Eligibility Criteria
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Inclusion Criteria
2. Be between 8 and 12 years of age inclusive at the time of enrollment.
3. 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
4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
5. Anisometropia: ≤ 1.50D SERE.
6. Astigmatism: ≤ 0.75 D
7. Free of ocular disease or abnormalities (including any corneal scar)
8. Currently have good general health.
9. Agree to accept the lens as assigned by the randomization.
10. Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
11. 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.
12. Able to maintain the visit schedule.
13. Willingness to participate in the trial for 4 years.
14. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
15. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
Exclusion Criteria
2. 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.
3. Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
4. 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.
5. 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)
6. Keratoconus or an irregular cornea.
7. Strabismus or amblyopia.
8. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
8 Years
12 Years
ALL
Yes
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Gleason, OD
Role: PRINCIPAL_INVESTIGATOR
Foresight Regulatory Strategies, Inc. (FRS)
Locations
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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
Chicago College of Optometry
Downers Grove, Illinois, United States
Carillon Vision Care
Glenview, Illinois, United States
Brain Vision Institute
Schaumburg, Illinois, United States
Clinical Optics Research Lab at IU School of Optometry
Bloomington, Indiana, 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
Utah Eye Centers
Ogden, Utah, United States
Virginia Pediatric Eye Care
Chesapeake, Virginia, United States
Factoria Eye Clinic
Bellevue, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Natalie West, O.D.
Role: primary
Erin Tomiyama, O.D., Ph.D.
Role: primary
Jamie Peters, O.D.
Role: primary
Vanessa Grichine, O.D.
Role: primary
Roxanne Achong-Coan, O.D.
Role: primary
Brianna Rhue, O.D.
Role: primary
Nathan Bonilla-Warford, O.D.
Role: primary
Katarzyna Aleszczyk, O.D.
Role: primary
Yi Pang, OD, PhD
Role: primary
Vakishan Nadarajah, O.D.
Role: primary
Andrew Neukirch, O.D.
Role: primary
Ingryd Lorenzana, O.D.
Role: primary
Peter Kollbaum, O.D.
Role: primary
Shane Kannarr, O.D.
Role: primary
Anh Bui, O.D.
Role: primary
Zachary Holland, O.D.
Role: primary
Ryan Powell, O.D.
Role: primary
Shane Foster, O.D.
Role: primary
Jennifer Fogt, O.D.
Role: primary
Katherine Bickle, O.D.
Role: primary
Keith Basinger, O.D.
Role: primary
Jason Miller, O.D.
Role: primary
Morgan Ollinger, O.D.
Role: primary
Samir N Patel, O.D.
Role: primary
Eric Ritchey, O.D.
Role: primary
Lawrence Wong, O.D.
Role: primary
Paola Diaz, O.D.
Role: primary
Michael Bullard, M.D.
Role: primary
Stacy Martinson, O.D.
Role: primary
Caroline Kaufman, O.D.
Role: primary
Other Identifiers
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PAS001/BC
Identifier Type: -
Identifier Source: org_study_id
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