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

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.

Study Overview

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

Detailed Description

This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years.

Part 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses.

Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama School of Optometry
      • Contact: Katherine Weise, OD, M.B.A.
  • California
    • Fullerton, California, United States, 92831
      • Recruiting
      • Marshall B. Ketchum University Southern California College of Optometry
      • Contact: Erin Tomiyama, O.D., Ph.D.
    • La Mesa, California, United States, 91942
      • Recruiting
      • Vision Solutions Optometry Inc
      • Contact: Jamie Peters
    • Santa Ana, California, United States, 92704
      • Recruiting
      • Paje Optometric
      • Contact: Vanessa Grichine, OD
  • Florida
    • Ocoee, Florida, United States, 34761
      • Recruiting
      • Coan Eye Care and Optical Boutique
      • Contact: Roxanne Achong-Coan
    • Sarasota, Florida, United States, 34237
      • Recruiting
      • Golden Vision
      • Contact: Wayne Golden, OD
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • West Broward Eyecare Associates
      • Contact: Brianna Rhue, O.D.
    • Tampa, Florida, United States, 33626
      • Recruiting
      • Bright Eyes Family Vision Care
      • Contact: Nathan Bonilla-Warford, O.D.
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Recruiting
      • Illinois College of Optometry
      • Contact: Yi Pang, OD, PhD
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • Solo Eye Care
      • Contact: Robert Steinmetz, O.D.
    • Glenview, Illinois, United States, 60025
      • Recruiting
      • Carillon Vision Care
      • Contact: Andrew Neukirch, O.D.
    • Palatine, Illinois, United States, 60067
      • Recruiting
      • Palatine Vision Center
      • Contact: Laura Rosanova-Philipp, O.D.
    • Schaumburg, Illinois, United States, 60194
      • Recruiting
      • Brain Vision Institute
      • Contact: Ingryd Lorenzana, O.D.
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Recruiting
      • Kannarr Eye Care
      • Contact: Shane Kannarr, O.D.
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • New England College of Optometry
      • Contact: Fuensanta Vera-Diaz, OD, Ph.D.
  • Minnesota
    • Edina, Minnesota, United States, 55436
      • Recruiting
      • Cornea and Contact Lens Institute
      • Contact: Zachary Holland, O.D.
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Vision Source EyeCare
      • Contact: Ryan Powell
  • Ohio
    • Athens, Ohio, United States, 45701
      • Recruiting
      • Athens Eye Care
      • Contact: Shane Foster, O.D.
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Contact: Jennifer Fogt
    • Granville, Ohio, United States, 43023
      • Recruiting
      • ProCare Vision Center, Inc.
      • Contact: Katherine Bickle
    • Miamisburg, Ohio, United States, 45342
      • Recruiting
      • Miamisburg Vision Care
      • Contact: Keith Basinger, OD
    • New Albany, Ohio, United States, 43054
      • Recruiting
      • Vision Professionals
      • Contact: Kyle Martin, OD
    • Powell, Ohio, United States, 43065
      • Recruiting
      • Eye Care Professionals
      • Contact: Jason Miller
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • Southern College of Optometry
      • Contact: Morgan Ollinger, OD
  • Texas
    • Beaumont, Texas, United States, 77706
      • Recruiting
      • Texas State Optical
      • Contact: Samir Patel
    • Houston, Texas, United States, 77095
      • Recruiting
      • Queenston Eye Care
      • Contact: Lucy (Zhou) Chen, OD
    • Katy, Texas, United States, 77450
      • Recruiting
      • Vision One Eyecare
      • Contact: Lawrence Wong, OD
    • Plano, Texas, United States, 75024
      • Recruiting
      • Lone Star Vision
      • Contact: Paola Diaz, O.D.
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Recruiting
      • Virginia Pediatric Eye Care
      • Contact: Stacy Martinson, OD
  • Washington
    • Bellevue, Washington, United States, 98006
      • Recruiting
      • Factoria Eye Clinic
      • Contact: Caroline Kaufman, O.D.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MiSight 1 day	Device: MiSight 1 Day; Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
Active Comparator: Proclear 1 day	Device: Proclear 1 day; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with no appreciable myopic progression	Percentage of subjects with no appreciable myopic progression (-0.25D change or less)	3 years
Visual symptoms and the effects on activities of daily living	Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure	3 years

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: William Gleason, OD, Foresight Regulatory Strategies, Inc. (FRS)

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 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): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: PAS001/BC

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