Actively Recruiting

Phase Not Applicable
Age: 8Years - 12Years
All Genders
Healthy Volunteers
NCT05285527

MiSight 1 Day Safety Post-Approval Study

Led by CooperVision, Inc. · Updated on 2025-08-14

2400

Participants Needed

50

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MiSight 1 Day Safety Post-Approval Study

Who Can Participate

Age: 8Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 8 and 12 years of age inclusive at the time of enrollment.
  • Have a spherical equivalent refractive error (SERE) between -0.50 D and -7.00 D inclusive at baseline.
  • Have best-corrected visual acuity of at least 20/25 in both eyes.
  • Be free of any eye disease or abnormalities including corneal scars.
  • Have a parent or guardian capable of understanding the study and consenting to use of the child's health data.
  • Obtain assent from the child as specified by the IRB.
  • Parent or guardian must sign a release for medical records related to study outcomes.
  • Be interested in wearing contact lenses about 10 hours per day, 6 days per week.
  • Possess or obtain eyeglasses with 20/40 vision or better before lens dispensing.
Not Eligible

You will not qualify if you...

  • Have acute or subacute inflammation or infection in the front part of the eye.
  • Have any eye disease, injury, or abnormality affecting the cornea, conjunctiva, or eyelids.
  • Have severe dry eyes (lacrimal secretion insufficiency).
  • Have reduced corneal sensitivity (corneal hypoesthesia) unless aphakic.
  • Have systemic diseases that affect the eye or could worsen with contact lens wear.
  • Have allergic reactions on the eye surface or surrounding areas that may worsen with contact lenses or lens solutions.
  • Have any active corneal infection (bacterial, fungal, or viral).
  • Have red or irritated eyes.
  • Be unable to follow lens handling or wear instructions or unable to get help to do so.
  • Be taking medications that interfere with contact lens wear or drugs to control myopia.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 50 locations

1

Experts on Sight LLC.

Gilbert, Arizona, United States, 85297

Actively Recruiting

2

Centerton Family Eyecare

Centerton, Arkansas, United States, 72719

Actively Recruiting

3

University of California, Berkeley University Eye Center

Berkeley, California, United States, 94720

Actively Recruiting

4

Golden Vision Cupertino Optometry

Cupertino, California, United States, 95014

Actively Recruiting

5

Boghossian Vision

Danville, California, United States, 94506

Actively Recruiting

6

Iron Horse Optometric Group

Dublin, California, United States, 94568

Actively Recruiting

7

Capitol Eye Care Center Optometry

Fremont, California, United States, 94536

Actively Recruiting

8

Irvine Eye Physicians and Surgeons Inc

Irvine, California, United States, 92618

Actively Recruiting

9

Elsa Pao OD, Inc

Oakland, California, United States, 94607

Actively Recruiting

10

Perfect Pair Optometry

San Jose, California, United States, 95118

Actively Recruiting

11

Almaden Family Optometric Center

San Jose, California, United States, 95120

Actively Recruiting

12

Children's Eye Physicians

Centennial, Colorado, United States, 80112

Actively Recruiting

13

Eye Physicians & Surgeons, PC

Milford, Connecticut, United States, 06460

Actively Recruiting

14

Planet Vision Eyecare

Lake Worth, Florida, United States, 33467

Actively Recruiting

15

Marino Eye Care

Miami, Florida, United States, 33156

Actively Recruiting

16

Vision Source Oviedo, INC

Oviedo, Florida, United States, 32765

Actively Recruiting

17

Dau Family Eye Care

Saint Johns, Florida, United States, 32259

Actively Recruiting

18

Gulf Coast Eye Center

Sarasota, Florida, United States, 34239

Actively Recruiting

19

Weston Contact Lens Institute LLC

Weston, Florida, United States, 33331

Actively Recruiting

20

Lurie Childrens

Chicago, Illinois, United States, 60611

Actively Recruiting

21

Lyons Family Eye Care P.C.

Chicago, Illinois, United States, 60657

Actively Recruiting

22

Darien Eye Specialists

Darien, Illinois, United States, 60561

Actively Recruiting

23

Carillon Vision Care

Glenview, Illinois, United States, 60025

Actively Recruiting

24

Little Eyes Pediatric Eye Care

Carmel, Indiana, United States, 46032

Actively Recruiting

25

All Eyes on Rockville

Rockville, Maryland, United States, 20852

Actively Recruiting

26

Wellesley Vision Group at Optical Design

Wellesley, Massachusetts, United States, 02482

Actively Recruiting

27

Missouri Eye Consultants - California

California, Missouri, United States, 65018

Actively Recruiting

28

Center for Vision and Learning

Des Peres, Missouri, United States, 63131

Actively Recruiting

29

Advocare Pediatric Eye Physicians

Morristown, New Jersey, United States, 07960

Actively Recruiting

30

Bronx Eye Associates

The Bronx, New York, United States, 10467

Actively Recruiting

31

Clarity Vision

Apex, North Carolina, United States, 27502

Actively Recruiting

32

Cary Family Eye Care

Cary, North Carolina, United States, 27519

Actively Recruiting

33

Chagrin Valley Optometrists, Inc.

Chagrin Falls, Ohio, United States, 44023

Actively Recruiting

34

Pickerington Eye Care

Pickerington, Ohio, United States, 43147

Actively Recruiting

35

Nittany Eye Associates, LLC

State College, Pennsylvania, United States, 16801

Actively Recruiting

36

Texas State Optical

Beaumont, Texas, United States, 77706

Actively Recruiting

37

Bellaire Family Eye Care

Bellaire, Texas, United States, 77401

Actively Recruiting

38

Drs. McIntyre, Garza, Avila and Jurica, Optometrists

Corpus Christi, Texas, United States, 78411

Actively Recruiting

39

Clarkson EyeCare KIDS

Frisco, Texas, United States, 75034

Actively Recruiting

40

Lone Star Vision Center

Plano, Texas, United States, 75024

Actively Recruiting

41

Stone Oak Vision Source

San Antonio, Texas, United States, 78258

Actively Recruiting

42

Child & Family Eye Care Center

Pleasant Grove, Utah, United States, 84062

Actively Recruiting

43

Broadway Eye Clinic

Salt Lake City, Utah, United States, 84111

Actively Recruiting

44

Invision Eye Health

Sandy City, Utah, United States, 84070

Actively Recruiting

45

Colonial Eye Care

Williamsburg, Virginia, United States, 23185

Actively Recruiting

46

Redmond Eye Clinic

Redmond, Washington, United States, 98052

Actively Recruiting

47

Spectrum Optical, PLLC

Morgantown, West Virginia, United States, 26505

Actively Recruiting

48

Dr. Kit Guan & Associates

Markham, Ontario, Canada, L3R3P9

Actively Recruiting

49

Abbey Eye Care

Oakville, Ontario, Canada, L6M5A9

Actively Recruiting

50

Optometry Professional Corporation

Toronto, Ontario, Canada, M2N 3A1

Actively Recruiting

Loading map...

Research Team

K

Kathryn Richdale, OD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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MiSight 1 Day Safety Post-Approval Study | DecenTrialz