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

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MiSight 1 Day
Proclear 1 day
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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).
  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 contrast 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.

Sites / Locations

  • University of Alabama School of OptometryRecruiting
  • Marshall B. Ketchum University Southern California College of OptometryRecruiting
  • Vision Solutions Optometry IncRecruiting
  • Paje OptometricRecruiting
  • Coan Eye Care and Optical BoutiqueRecruiting
  • Golden VisionRecruiting
  • West Broward Eyecare AssociatesRecruiting
  • Bright Eyes Family Vision CareRecruiting
  • Roswell Eye ClinicRecruiting
  • Solo Eye CareRecruiting
  • Carillon Vision CareRecruiting
  • Palatine Vision CenterRecruiting
  • Brain Vision InstituteRecruiting
  • Kannarr Eye CareRecruiting
  • New England College of OptometryRecruiting
  • Cornea and Contact Lens InstituteRecruiting
  • Vision Source EyeCareRecruiting
  • Athens Eye CareRecruiting
  • Ohio State UniversityRecruiting
  • ProCare Vision Center, Inc.Recruiting
  • Eye Care ProfessionalsRecruiting
  • Texas State OpticalRecruiting
  • Lone Star VisionRecruiting
  • Factoria Eye ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiSight 1 day

Proclear 1 day

Arm Description

MiSight 1 day

Proclear 1 day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of subjects with no appreciable myopic progression
Percentage of subjects with no appreciable myopic progression (-0.25D change or less)
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

Full Information

First Posted
March 9, 2022
Last Updated
September 29, 2023
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05285553
Brief Title
MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
Official Title
MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2022 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MiSight 1 day
Arm Type
Experimental
Arm Description
MiSight 1 day
Arm Title
Proclear 1 day
Arm Type
Active Comparator
Arm Description
Proclear 1 day
Intervention Type
Device
Intervention Name(s)
MiSight 1 Day
Intervention Description
Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
Intervention Type
Device
Intervention Name(s)
Proclear 1 day
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean difference in cycloplegic SERE change from baseline
Description
Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters
Time Frame
3 years
Title
Mean difference in axial length change from baseline
Description
Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters
Time Frame
3 years
Title
Mean difference in rate of cycloplegic SERE change - Part 2 study
Description
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
Time Frame
1 year
Title
Mean difference in rate of axial length - Part 2 study
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of subjects with no appreciable myopic progression
Description
Percentage of subjects with no appreciable myopic progression (-0.25D change or less)
Time Frame
3 years
Title
Visual symptoms and the effects on activities of daily living
Description
Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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) Keratoconus or an irregular cornea. Strabismus or amblyopia. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Richdale, OD, PhD
Phone
917-755-4548
Email
krichdale@coopervision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gleason, OD
Organizational Affiliation
Foresight Regulatory Strategies, Inc. (FRS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama School of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Weise, OD, M.B.A.
Facility Name
Marshall B. Ketchum University Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Tomiyama, O.D., Ph.D.
Facility Name
Vision Solutions Optometry Inc
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Peters
Facility Name
Paje Optometric
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Grichine, OD
Facility Name
Coan Eye Care and Optical Boutique
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roxanne Achong-Coan
Facility Name
Golden Vision
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Golden, OD
Facility Name
West Broward Eyecare Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianna Rhue, O.D.
Facility Name
Bright Eyes Family Vision Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33626
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Bonilla-Warford, O.D.
Facility Name
Roswell Eye Clinic
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Moscow, O.D.
Facility Name
Solo Eye Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Steinmetz, O.D.
Facility Name
Carillon Vision Care
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Neukirch, O.D.
Facility Name
Palatine Vision Center
City
Palatine
State/Province
Illinois
ZIP/Postal Code
60067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Rosanova-Philipp, O.D.
Facility Name
Brain Vision Institute
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingryd Lorenzana, O.D.
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane Kannarr, O.D.
Facility Name
New England College of Optometry
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuensanta Vera-Diaz, OD, Ph.D.
Facility Name
Cornea and Contact Lens Institute
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Holland, O.D.
Facility Name
Vision Source EyeCare
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Powell
Facility Name
Athens Eye Care
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane Foster, O.D.
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Fogt
Facility Name
ProCare Vision Center, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Bickle
Facility Name
Eye Care Professionals
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Miller
Facility Name
Texas State Optical
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Patel
Facility Name
Lone Star Vision
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Diaz, O.D.
Facility Name
Factoria Eye Clinic
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Kaufman, O.D.

12. IPD Sharing Statement

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

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