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

NCT05285553 | Recruiting DMC FDA Device

• 1 other identifier: PAS001/BC
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 30

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Mean difference in cycloplegic SERE change from baseline

  Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters

  3 years

• Mean difference in axial length change from baseline

  Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters

  3 years

• Mean difference in rate of cycloplegic SERE change - Part 2 study

  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

  1 year

• Mean difference in rate of axial length - Part 2 study

  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.

  1 year

Secondary Outcomes (2)

• Percentage of subjects with no appreciable myopic progression

  3 years

• Visual symptoms and the effects on activities of daily living

  3 years

Study Arms (2)

MiSight 1 day

EXPERIMENTAL

MiSight 1 day

Device: MiSight 1 Day

Proclear 1 day

ACTIVE COMPARATOR

Proclear 1 day

Device: Proclear 1 day

Interventions

MiSight 1 Day DEVICE

Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.

MiSight 1 day

Proclear 1 day DEVICE

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.

Proclear 1 day

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
• 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.
• Has history of:
• Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (30)

University of Alabama School of Optometry

Birmingham, Alabama, 35233, United States

RECRUITING

Marshall B. Ketchum University Southern California College of Optometry

Fullerton, California, 92831, United States

RECRUITING

Vision Solutions Optometry Inc

La Mesa, California, 91942, United States

RECRUITING

Paje Optometric

Santa Ana, California, 92704, United States

RECRUITING

Coan Eye Care and Optical Boutique

Ocoee, Florida, 34761, United States

RECRUITING

West Broward Eyecare Associates

Tamarac, Florida, 33321, United States

RECRUITING

Bright Eyes Family Vision Care

Tampa, Florida, 33626, United States

RECRUITING

SoLo Eye Care & Eyewear Gallery

Chicago, Illinois, 60608, United States

RECRUITING

Illinois College of Optometry

Chicago, Illinois, 60616, United States

RECRUITING

Chicago College of Optometry

Downers Grove, Illinois, 60515, United States

RECRUITING

Carillon Vision Care

Glenview, Illinois, 60025, United States

RECRUITING

Brain Vision Institute

Schaumburg, Illinois, 60194, United States

RECRUITING

Clinical Optics Research Lab at IU School of Optometry

Bloomington, Indiana, 47406, United States

RECRUITING

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

New England College of Optometry

Boston, Massachusetts, 02115, United States

RECRUITING

Cornea and Contact Lens Institute

Edina, Minnesota, 55436, United States

RECRUITING

Vision Source EyeCare

Kansas City, Missouri, 64111, United States

RECRUITING

Athens Eye Care

Athens, Ohio, 45701, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

ProCare Vision Center, Inc.

Granville, Ohio, 43023, United States

RECRUITING

Miamisburg Vision Care

Miamisburg, Ohio, 45342, United States

RECRUITING

Eye Care Professionals

Powell, Ohio, 43065, United States

RECRUITING

Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

Texas State Optical

Beaumont, Texas, 77706, United States

RECRUITING

University of Houston College of Optometry

Houston, Texas, 77204, United States

RECRUITING

Vision One Eyecare

Katy, Texas, 77450, United States

RECRUITING

Lone Star Vision

Plano, Texas, 75024, United States

RECRUITING

Utah Eye Centers

Ogden, Utah, 84403, United States

RECRUITING

Virginia Pediatric Eye Care

Chesapeake, Virginia, 23320, United States

RECRUITING

Factoria Eye Clinic

Bellevue, Washington, 98006, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• William Gleason, OD

  Foresight Regulatory Strategies, Inc. (FRS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Richdale, OD, PhD

CONTACT

917-755-4548; MiSight.EfficacyPAS@coopervision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: June 25, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (30)