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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285553
• Other study ID #: PAS001/BC
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2023
• Source: Coopervision, Inc.
• Contact: Kathryn Richdale, OD, PhD
• Phone: 917-755-4548
• Email: krichdale[@]coopervision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• MiSight 1 Day
Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
• 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.

Locations

Country	Name	City	State
United States	Athens Eye Care	Athens	Ohio
United States	Texas State Optical	Beaumont	Texas
United States	Factoria Eye Clinic	Bellevue	Washington
United States	University of Alabama School of Optometry	Birmingham	Alabama
United States	New England College of Optometry	Boston	Massachusetts
United States	Virginia Pediatric Eye Care	Chesapeake	Virginia
United States	Illinois College of Optometry	Chicago	Illinois
United States	Solo Eye Care	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Cornea and Contact Lens Institute	Edina	Minnesota
United States	Marshall B. Ketchum University Southern California College of Optometry	Fullerton	California
United States	Carillon Vision Care	Glenview	Illinois
United States	ProCare Vision Center, Inc.	Granville	Ohio
United States	Queenston Eye Care	Houston	Texas
United States	Vision Source EyeCare	Kansas City	Missouri
United States	Vision One Eyecare	Katy	Texas
United States	Vision Solutions Optometry Inc	La Mesa	California
United States	Southern College of Optometry	Memphis	Tennessee
United States	Miamisburg Vision Care	Miamisburg	Ohio
United States	Vision Professionals	New Albany	Ohio
United States	Coan Eye Care and Optical Boutique	Ocoee	Florida
United States	Palatine Vision Center	Palatine	Illinois
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Lone Star Vision	Plano	Texas
United States	Eye Care Professionals	Powell	Ohio
United States	Paje Optometric	Santa Ana	California
United States	Golden Vision	Sarasota	Florida
United States	Brain Vision Institute	Schaumburg	Illinois
United States	West Broward Eyecare Associates	Tamarac	Florida
United States	Bright Eyes Family Vision Care	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of subjects with no appreciable myopic progression	Percentage of subjects with no appreciable myopic progression (-0.25D change or less)	3 years
Secondary	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