Actively Recruiting

Phase Not Applicable
Age: 8Years - 12Years
All Genders
Healthy Volunteers
NCT05285553

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

Led by CooperVision, Inc. · Updated on 2025-08-17

900

Participants Needed

30

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 8Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed Consent and Assent have been completed
  • Be between 8 and 12 years of age inclusive at the time of enrollment
  • Spherical Equivalent Refractive Error between -0.75 D and -4.00 D at baseline in each eye
  • Best-corrected visual acuity of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye
  • Anisometropia of 1.50 D SERE or less
  • Astigmatism of 0.75 D or less
  • Free of ocular disease or abnormalities including any corneal scar
  • Currently have good general health
  • Agree to accept the lens assigned by randomization
  • Able to understand the study and willing to follow study instructions
  • Able to comply with study procedures including visual acuity and eye measurements
  • Able to maintain the visit schedule
  • Willing to participate in the trial for 4 years
  • Interested in wearing contact lenses approximately 10 hours per day, 6 days per week
  • Possesses or will obtain wearable and visually functional eyeglasses (20/40 or better)
Not Eligible

You will not qualify if you...

  • Current or prior use of any myopia control methods such as bifocals, progressive addition lenses, orthokeratology, atropine, or pirenzepine
  • Use of any medications or artificial tears that interfere with contact lens wear or eye measurements
  • Previously worn or currently wearing rigid gas permeable contact lenses including orthokeratology lenses
  • Any acute or subacute inflammation or infection of the anterior eye chamber
  • Any eye disease, injury, or abnormality affecting the cornea, conjunctiva, or eyelids
  • Severe dry eyes
  • Corneal hypoesthesia unless aphakic
  • Any systemic disease affecting the eye or worsened by contact lenses
  • Allergic reactions to contact lenses or solutions
  • Any active corneal infection
  • Eyes that are red or irritated
  • Inability to follow lens handling or wear regimen
  • History of corneal ulcers, infiltrates, viral or fungal infections, or recurrent ocular infections
  • Giant papillary conjunctivitis
  • Known allergy to fluorescein, benoxinate, proparacaine, or tropicamide
  • Keratoconus or irregular cornea
  • Strabismus or amblyopia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

University of Alabama School of Optometry

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Marshall B. Ketchum University Southern California College of Optometry

Fullerton, California, United States, 92831

Actively Recruiting

3

Vision Solutions Optometry Inc

La Mesa, California, United States, 91942

Actively Recruiting

4

Paje Optometric

Santa Ana, California, United States, 92704

Actively Recruiting

5

Coan Eye Care and Optical Boutique

Ocoee, Florida, United States, 34761

Actively Recruiting

6

West Broward Eyecare Associates

Tamarac, Florida, United States, 33321

Actively Recruiting

7

Bright Eyes Family Vision Care

Tampa, Florida, United States, 33626

Actively Recruiting

8

SoLo Eye Care & Eyewear Gallery

Chicago, Illinois, United States, 60608

Actively Recruiting

9

Illinois College of Optometry

Chicago, Illinois, United States, 60616

Actively Recruiting

10

Chicago College of Optometry

Downers Grove, Illinois, United States, 60515

Actively Recruiting

11

Carillon Vision Care

Glenview, Illinois, United States, 60025

Actively Recruiting

12

Brain Vision Institute

Schaumburg, Illinois, United States, 60194

Actively Recruiting

13

Clinical Optics Research Lab at IU School of Optometry

Bloomington, Indiana, United States, 47406

Actively Recruiting

14

Kannarr Eye Care

Pittsburg, Kansas, United States, 66762

Actively Recruiting

15

New England College of Optometry

Boston, Massachusetts, United States, 02115

Actively Recruiting

16

Cornea and Contact Lens Institute

Edina, Minnesota, United States, 55436

Actively Recruiting

17

Vision Source EyeCare

Kansas City, Missouri, United States, 64111

Actively Recruiting

18

Athens Eye Care

Athens, Ohio, United States, 45701

Actively Recruiting

19

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

20

ProCare Vision Center, Inc.

Granville, Ohio, United States, 43023

Actively Recruiting

21

Miamisburg Vision Care

Miamisburg, Ohio, United States, 45342

Actively Recruiting

22

Eye Care Professionals

Powell, Ohio, United States, 43065

Actively Recruiting

23

Southern College of Optometry

Memphis, Tennessee, United States, 38104

Actively Recruiting

24

Texas State Optical

Beaumont, Texas, United States, 77706

Actively Recruiting

25

University of Houston College of Optometry

Houston, Texas, United States, 77204

Actively Recruiting

26

Vision One Eyecare

Katy, Texas, United States, 77450

Actively Recruiting

27

Lone Star Vision

Plano, Texas, United States, 75024

Actively Recruiting

28

Utah Eye Centers

Ogden, Utah, United States, 84403

Actively Recruiting

29

Virginia Pediatric Eye Care

Chesapeake, Virginia, United States, 23320

Actively Recruiting

30

Factoria Eye Clinic

Bellevue, Washington, United States, 98006

Actively Recruiting

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Research Team

K

Kathryn Richdale, OD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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