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
2400 participants
INTERVENTIONAL
2022-08-15
2027-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MiSight 1 Day
MiSight 1 Day
MiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.
Interventions
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MiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
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
Locations
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Experts on Sight LLC.
Gilbert, Arizona, United States
Centerton Family Eyecare
Centerton, Arkansas, United States
University of California, Berkeley University Eye Center
Berkeley, California, United States
Golden Vision Cupertino Optometry
Cupertino, California, 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
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
Dau Family Eye Care
Saint Johns, Florida, United States
Gulf Coast Eye Center
Sarasota, 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
Bronx Eye Associates
The Bronx, New York, 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
Drs. McIntyre, Garza, Avila and Jurica, Optometrists
Corpus Christi, 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 City, Utah, United States
Colonial Eye Care
Williamsburg, Virginia, United States
Redmond Eye Clinic
Redmond, Washington, United States
Spectrum Optical, PLLC
Morgantown, West Virginia, United States
Dr. Kit Guan & Associates
Markham, Ontario, Canada
Abbey Eye Care
Oakville, Ontario, Canada
Optometry Professional Corporation
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Jashpal Rajasansi, O.D.
Role: primary
Megan Petty, OD
Role: primary
Yue (Maria) Liu, O.D.
Role: primary
Pearl Shih, O.D.
Role: primary
Margaret Burton, OD
Role: primary
Sara Chiu, OD
Role: primary
Stella Levin, OD
Role: primary
David W Chia, MD
Role: primary
Elsa Pao, OD
Role: primary
Brian H Kitajima, OD
Role: primary
Pei-Chen (Jennifer) Hsieh, O.D.
Role: primary
Rebecca Phung, OD
Role: primary
Darron Bacal, O.D.
Role: primary
Hetel Bhakta, OD
Role: primary
Vanessa C Marino, OD
Role: primary
David Fisher, O.D.
Role: primary
Jordan Dau, OD
Role: primary
Steven Bovio, OD
Role: primary
Elise Kramer, OD
Role: primary
Noreen Shaikh, O.D.
Role: primary
Stephanie Lyons, OD
Role: primary
Shinu Varghese, OD
Role: primary
Andrew Neukirch, OD
Role: primary
Katherine Schuetz, O.D.
Role: primary
Hannah Neubauer, OD
Role: primary
Anhthy T. Prendeville, O.D.
Role: primary
Jacqueline Bryd, O.D.
Role: primary
Cheryl Davidson, O.D.
Role: primary
Lucy Chen, MD
Role: primary
Eleonora Orloff, O.D.
Role: primary
David J Holler, OD
Role: primary
Dwight Barnes, OD
Role: primary
Jenna Lewis, OD
Role: primary
Eriq Hall, OD
Role: primary
Michael Cymbor, OD
Role: primary
Samir N Patel, OD
Role: primary
Ashley W Tucker, OD
Role: primary
Amy Luu Mai, O.D.
Role: primary
Carlee Young, O.D.
Role: primary
Paola Diaz, OD
Role: primary
Mann Chandler, OD
Role: primary
Jeremy Gardner, O.D.
Role: primary
Karri Buresh, OD
Role: primary
Christopher Snow, O.D.
Role: primary
Kelsey Guth, OD
Role: primary
Jeffrey Binstock, DVM, OD
Role: primary
Jordan Hamric, O.D.
Role: primary
Kit Guan, OD
Role: primary
Tina Goodhew, OD
Role: primary
Fiona Soong, Dr.
Role: primary
Other Identifiers
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PAS002
Identifier Type: -
Identifier Source: org_study_id
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