RECRUITING

MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms

Conditions

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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 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.

Official Title

MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms

Quick Facts

Study Start:2022-06-25

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05285553

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 Criteria	Exclusion Criteria
1. Informed Consent and Assent have been completed 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.	1. 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. 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.

Inclusion Criteria

Exclusion Criteria

1. Informed Consent and Assent have been completed
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.

1. 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.
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.

Contacts and Locations

Study Contact

Kathryn Richdale, OD, PhD

CONTACT

917-755-4548

MiSight.EfficacyPAS@coopervision.com

Principal Investigator

William Gleason, OD

PRINCIPAL_INVESTIGATOR

Foresight Regulatory Strategies, Inc. (FRS)

Study Locations (Sites)

University of Alabama School of Optometry

Birmingham, Alabama, 35233

United States

Marshall B. Ketchum University Southern California College of Optometry

Fullerton, California, 92831

United States

Vision Solutions Optometry Inc

La Mesa, California, 91942

United States

Paje Optometric

Santa Ana, California, 92704

United States

Nova Southeastern University (NSU) College of Optometry

Fort Lauderdale, Florida, 33328

United States

Coan Eye Care and Optical Boutique

Ocoee, Florida, 34761

United States

West Broward Eyecare Associates

Tamarac, Florida, 33321

United States

Bright Eyes Family Vision Care

Tampa, Florida, 33626

United States

SoLo Eye Care & Eyewear Gallery

Chicago, Illinois, 60608

United States

Illinois College of Optometry

Chicago, Illinois, 60616

United States

Chicago College of Optometry

Downers Grove, Illinois, 60515

United States

Carillon Vision Care

Glenview, Illinois, 60025

United States

Brain Vision Institute

Schaumburg, Illinois, 60194

United States

Kannarr Eye Care

Pittsburg, Kansas, 66762

United States

New England College of Optometry

Boston, Massachusetts, 02115

United States

Cornea and Contact Lens Institute

Edina, Minnesota, 55436

United States

Vision Source EyeCare

Kansas City, Missouri, 64111

United States

Athens Eye Care

Athens, Ohio, 45701

United States

Ohio State University

Columbus, Ohio, 43210

United States

ProCare Vision Center, Inc.

Granville, Ohio, 43023

United States

Miamisburg Vision Care

Miamisburg, Ohio, 45342

United States

Eye Care Professionals

Powell, Ohio, 43065

United States

Southern College of Optometry

Memphis, Tennessee, 38104

United States

Texas State Optical

Beaumont, Texas, 77706

United States

University of Houston College of Optometry

Houston, Texas, 77204

United States

Vision One Eyecare

Katy, Texas, 77450

United States

Lone Star Vision

Plano, Texas, 75024

United States

Utah Eye Centers

Ogden, Utah, 84403

United States

Virginia Pediatric Eye Care

Chesapeake, Virginia, 23320

United States

Factoria Eye Clinic

Bellevue, Washington, 98006

United States

Collaborators and Investigators

Sponsor: Coopervision, Inc.

William Gleason, OD, PRINCIPAL_INVESTIGATOR, Foresight Regulatory Strategies, Inc. (FRS)

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 Date2022-06-25

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2022-06-25

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

Myopia