RECRUITING

MiSight 1 Day Safety Post-Approval Study

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Conditions

Myopia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MiSight 1 Day Safety Post-Approval Study

Quick Facts

Study Start:2022-08-15
Study Completion:2027-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05285527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Be between 8 and 12 years of age inclusive at the time of enrollment.
  2. 2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
  3. 3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
  4. 4. Free of ocular disease or abnormalities (including any corneal scar)
  5. 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. 6. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
  7. 7. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
  8. 8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
  1. 1. Acute and subacute inflammation or infection of the anterior chamber of the eye.
  2. 2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
  3. 3. Severe insufficiency of lacrimal secretion (dry eyes).
  4. 4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
  5. 5. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
  6. 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. 7. Any active corneal infection (bacterial, fungal, or viral).
  8. 8. If eyes are red or irritated.
  9. 9. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
  10. 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.

Contacts and Locations

Study Contact

Kathryn Richdale, OD, PhD
CONTACT
917-755-4548
MiSight.SafetyPAS@coopervision.com

Principal Investigator

William Gleason, OD
PRINCIPAL_INVESTIGATOR
Foresight Regulatory Strategies

Study Locations (Sites)

Experts on Sight LLC.
Gilbert, Arizona, 85297
United States
Centerton Family Eyecare
Centerton, Arkansas, 72719
United States
University of California, Berkeley University Eye Center
Berkeley, California, 94720
United States
Golden Vision Cupertino Optometry
Cupertino, California, 95014
United States
Boghossian Vision
Danville, California, 94506
United States
Iron Horse Optometric Group
Dublin, California, 94568
United States
Capitol Eye Care Center Optometry
Fremont, California, 94536
United States
Irvine Eye Physicians and Surgeons Inc
Irvine, California, 92618
United States
Elsa Pao OD, Inc
Oakland, California, 94607
United States
Perfect Pair Optometry
San Jose, California, 95118
United States
Almaden Family Optometric Center
San Jose, California, 95120
United States
Children's Eye Physicians
Centennial, Colorado, 80112
United States
Eye Physicians & Surgeons, PC
Milford, Connecticut, 06460
United States
Planet Vision Eyecare
Lake Worth, Florida, 33467
United States
Marino Eye Care
Miami, Florida, 33156
United States
Vision Source Oviedo, INC
Oviedo, Florida, 32765
United States
Gulf Coast Eye Center
Sarasota, Florida, 34239
United States
Dau Family Eye Care
St. Johns, Florida, 32259
United States
Weston Contact Lens Institute LLC
Weston, Florida, 33331
United States
Lurie Childrens
Chicago, Illinois, 60611
United States
Lyons Family Eye Care P.C.
Chicago, Illinois, 60657
United States
Darien Eye Specialists
Darien, Illinois, 60561
United States
Carillon Vision Care
Glenview, Illinois, 60025
United States
Little Eyes Pediatric Eye Care
Carmel, Indiana, 46032
United States
All Eyes on Rockville
Rockville, Maryland, 20852
United States
Wellesley Vision Group at Optical Design
Wellesley, Massachusetts, 02482
United States
Missouri Eye Consultants - California
California, Missouri, 65018
United States
Center for Vision and Learning
Des Peres, Missouri, 63131
United States
Advocare Pediatric Eye Physicians
Morristown, New Jersey, 07960
United States
Bronx Eye Associates
Bronx, New York, 10467
United States
Clarity Vision
Apex, North Carolina, 27502
United States
Cary Family Eye Care
Cary, North Carolina, 27519
United States
Chagrin Valley Optometrists, Inc.
Chagrin Falls, Ohio, 44023
United States
Pickerington Eye Care
Pickerington, Ohio, 43147
United States
Nittany Eye Associates, LLC
State College, Pennsylvania, 16801
United States
Texas State Optical
Beaumont, Texas, 77706
United States
Bellaire Family Eye Care
Bellaire, Texas, 77401
United States
Drs. McIntyre, Garza, Avila and Jurica, Optometrists
Corpus Christi, Texas, 78411
United States
Clarkson EyeCare KIDS
Frisco, Texas, 75034
United States
Lone Star Vision Center
Plano, Texas, 75024
United States
Stone Oak Vision Source
San Antonio, Texas, 78258
United States
Child & Family Eye Care Center
Pleasant Grove, Utah, 84062
United States
Broadway Eye Clinic
Salt Lake City, Utah, 84111
United States
Invision Eye Health
Sandy, Utah, 84070
United States
Colonial Eye Care
Williamsburg, Virginia, 23185
United States
Redmond Eye Clinic
Redmond, Washington, 98052
United States
Spectrum Optical, PLLC
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Coopervision, Inc.

  • William Gleason, OD, PRINCIPAL_INVESTIGATOR, Foresight Regulatory Strategies

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

Study Start Date2022-08-15
Study Completion Date2027-05-30

Study Record Updates

Study Start Date2022-08-15
Study Completion Date2027-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Myopia