MiSight 1 Day Safety Post-Approval Study

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: MiSight 1 Day

Detailed Description

This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn Richdale, OD, PhD; Phone Number: 917-755-4548; Email: MiSight.SafetyPAS@coopervision.com

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3R3P9
      • Recruiting
      • Dr. Kit Guan & Associates
      • Contact: Kit Guan, OD; Phone Number: 905-604-4122
    • Oakville, Ontario, Canada, L6M5A9
      • Recruiting
      • Abbey Eye Care
      • Contact: Tina Goodhew, OD; Phone Number: 905-847-3937
    • Toronto, Ontario, Canada, M2N 3A1
      • Recruiting
      • Optometry Professional Corporation
      • Contact: Fiona Soong, Dr.
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Recruiting
      • Experts on Sight LLC.
      • Contact: Jashpal Rajasansi, O.D.
  • Arkansas
    • Centerton, Arkansas, United States, 72719
      • Recruiting
      • Centerton Family Eyecare
      • Contact: Megan Petty, OD
  • California
    • Berkeley, California, United States, 94720
      • Recruiting
      • University of California, Berkeley University Eye Center
      • Contact: Yue (Maria) Liu, O.D.
    • Cupertino, California, United States, 95014
      • Recruiting
      • Golden Vision Cupertino Optometry
      • Contact: Pearl Shih, O.D.
    • Danville, California, United States, 94506
      • Recruiting
      • Boghossian Vision
      • Contact: Margaret Burton, OD
    • Dublin, California, United States, 94568
      • Recruiting
      • Iron Horse Optometric Group
      • Contact: Sara Chiu, OD
    • Fremont, California, United States, 94536
      • Recruiting
      • Capitol Eye Care Center Optometry
      • Contact: Stella Levin, OD
    • Irvine, California, United States, 92618
      • Recruiting
      • Irvine Eye Physicians and Surgeons Inc
      • Contact: David W Chia, MD
    • Oakland, California, United States, 94607
      • Recruiting
      • Elsa Pao OD, Inc
      • Contact: Elsa Pao, OD
    • San Jose, California, United States, 95120
      • Recruiting
      • Almaden Family Optometric Center
      • Contact: Pei-Chen (Jennifer) Hsieh, O.D.
    • San Jose, California, United States, 95118
      • Recruiting
      • Perfect Pair Optometry
      • Contact: Brian H Kitajima, OD
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Recruiting
      • Children's Eye Physicians
      • Contact: Rebecca Phung, OD
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Recruiting
      • Eye Physicians & Surgeons, PC
      • Contact: Darron Bacal, O.D.
  • Florida
    • Lake Worth, Florida, United States, 33467
      • Recruiting
      • Planet Vision Eyecare
      • Contact: Hetel Bhakta, OD
    • Miami, Florida, United States, 33156
      • Recruiting
      • Marino Eye Care
      • Contact: Vanessa C Marino, OD
    • Oviedo, Florida, United States, 32765
      • Recruiting
      • Vision Source Oviedo, INC
      • Contact: David Fisher, O.D.
    • Saint Johns, Florida, United States, 32259
      • Recruiting
      • Dau Family Eye Care
      • Contact: Jordan Dau, OD
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Gulf Coast Eye Center
      • Contact: Steven Bovio, OD
    • Weston, Florida, United States, 33331
      • Recruiting
      • Weston Contact Lens Institute LLC
      • Contact: Elise Kramer, OD
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Recruiting
      • Lyons Family Eye Care P.C.
      • Contact: Stephanie Lyons, OD
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Lurie Childrens
      • Contact: Noreen Shaikh, O.D.
    • Darien, Illinois, United States, 60561
      • Recruiting
      • Darien Eye Specialists
      • Contact: Shinu Varghese, OD
    • Glenview, Illinois, United States, 60025
      • Recruiting
      • Carillon Vision Care
      • Contact: Andrew Neukirch, OD
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • Little Eyes Pediatric Eye Care
      • Contact: Katherine Schuetz, O.D.
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Recruiting
      • All Eyes on Rockville
      • Contact: Hannah Neubauer, OD
  • Massachusetts
    • Wellesley, Massachusetts, United States, 02482
      • Recruiting
      • Wellesley Vision Group at Optical Design
      • Contact: Anhthy T. Prendeville, O.D.
  • Missouri
    • California, Missouri, United States, 65018
      • Recruiting
      • Missouri Eye Consultants - California
      • Contact: Jacqueline Bryd, O.D.
    • Des Peres, Missouri, United States, 63131
      • Recruiting
      • Center for Vision and Learning
      • Contact: Cheryl Davidson, O.D.
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Advocare Pediatric Eye Physicians
      • Contact: Lucy Chen, MD
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Bronx Eye Associates
      • Contact: Eleonora Orloff, O.D.
  • North Carolina
    • Apex, North Carolina, United States, 27502
      • Recruiting
      • Clarity Vision
      • Contact: David J Holler, OD
    • Cary, North Carolina, United States, 27519
      • Recruiting
      • Cary Family Eye Care
      • Contact: Dwight Barnes, OD
  • Ohio
    • Chagrin Falls, Ohio, United States, 44023
      • Recruiting
      • Chagrin Valley Optometrists, Inc.
      • Contact: Jenna Lewis, OD
    • Pickerington, Ohio, United States, 43147
      • Recruiting
      • Pickerington Eye Care
      • Contact: Eriq Hall, OD
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Recruiting
      • Nittany Eye Associates, LLC
      • Contact: Michael Cymbor, OD
  • Texas
    • Beaumont, Texas, United States, 77706
      • Recruiting
      • Texas State Optical
      • Contact: Samir N Patel, OD
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Bellaire Family Eye Care
      • Contact: Ashley W Tucker, OD
    • Corpus Christi, Texas, United States, 78411
      • Recruiting
      • Drs. McIntyre, Garza, Avila and Jurica, Optometrists
      • Contact: Amy Luu Mai, O.D.
    • Frisco, Texas, United States, 75034
      • Recruiting
      • Clarkson EyeCare KIDS
      • Contact: Carlee Young, O.D.
    • Plano, Texas, United States, 75024
      • Recruiting
      • Lone Star Vision Center
      • Contact: Paola Diaz, OD
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • Stone Oak Vision Source
      • Contact: Mann Chandler, OD
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • Recruiting
      • Child & Family Eye Care Center
      • Contact: Jeremy Gardner, O.D.
    • Salt Lake City, Utah, United States, 84111
      • Recruiting
      • Broadway Eye Clinic
      • Contact: Karri Buresh, OD
    • Sandy, Utah, United States, 84070
      • Recruiting
      • Invision Eye Health
      • Contact: Christopher Snow, O.D.
  • Virginia
    • Williamsburg, Virginia, United States, 23185
      • Recruiting
      • Colonial Eye Care
      • Contact: Kelsey Guth, OD
  • Washington
    • Redmond, Washington, United States, 98052
      • Recruiting
      • Redmond Eye Clinic
      • Contact: Jeffrey Binstock, DVM, OD
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • Spectrum Optical, PLLC
      • Contact: Jordan Hamric, O.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be between 8 and 12 years of age inclusive at the time of enrollment.
2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
4. Free of ocular disease or abnormalities (including any corneal scar)
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. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
7. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

Exclusion Criteria:

1. Acute and subacute inflammation or infection of the anterior chamber of the eye.
2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
3. Severe insufficiency of lacrimal secretion (dry eyes).
4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
5. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
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. Any active corneal infection (bacterial, fungal, or viral).
8. If eyes are red or irritated.
9. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MiSight 1 Day	Device: MiSight 1 Day; Subjects will wear MiSight 1 day lenses for three years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Microbial Keratitis (MK)	Incidence of Microbial Keratitis (MK) ≥ 1 mm	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of peripheral infiltrative keratitis/non-infectious ulcers	Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm	3 years
Incidence of non-infectious infiltrative keratitis	Incidence of non-infectious infiltrative keratitis ≤ 1 mm	3 years
Incidence of loss of best-corrected visual acuity	Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event.	3 years

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: William Gleason, OD, Foresight Regulatory Strategies

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: PAS002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No