MiSight 1 Day Safety Post-Approval Study

Myopia Clinical Trial

Official title:

MiSight 1 Day Safety Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285527
• Other study ID #: PAS002
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: May 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 safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: May 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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 -0.75 D and -4.00 D inclusive (at the corneal plane).

3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally

4. Anisometropia: = 1.50D SERE.

5. Astigmatism: = -0.75 D

6. Free of ocular disease or abnormalities (including any corneal scar)

7. 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.

8. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.

9. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.

10. 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• MiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.

Locations

Country	Name	City	State
United States	Clarity Vision	Apex	North Carolina
United States	Texas State Optical	Beaumont	Texas
United States	Bellaire Family Eye Care	Bellaire	Texas
United States	Queens Optometric Care, Plc	Bronx	New York
United States	Missouri Eye Consultants - California	California	Missouri
United States	Little Eyes Pediatric Eye Care	Carmel	Indiana
United States	Children's Eye Physicians	Centennial	Colorado
United States	Chagrin Valley Optometrists, Inc.	Chagrin Falls	Ohio
United States	Lurie Childrens	Chicago	Illinois
United States	Lyons Family Eye Care P.C.	Chicago	Illinois
United States	Vision Golden Cupertino Optometry	Cupertino	California
United States	Boghossian Vision	Danville	California
United States	Center for Vision and Learning	Des Peres	Missouri
United States	Iron Horse Optometric Group	Dublin	California
United States	Capitol Eye Care Center Optometry	Fremont	California
United States	Clarkson EyeCare KIDS	Frisco	Texas
United States	Experts on Sight LLC.	Gilbert	Arizona
United States	Carillon Vision Care	Glenview	Illinois
United States	Irvine Eye Physicians and Surgeons Inc	Irvine	California
United States	Planet Vision Eyecare	Lake Worth	Florida
United States	Marino Eye Care	Miami	Florida
United States	Eye Physicians & Surgeons, PC	Milford	Connecticut
United States	Total Vision Golden Milpitas Optometry	Milpitas	California
United States	Spectrum Optical, PLLC	Morgantown	West Virginia
United States	Advocare Pediatric Eye Physicians	Morristown	New Jersey
United States	Elsa Pao OD, Inc	Oakland	California
United States	Vision Source Oviedo, INC	Oviedo	Florida
United States	Pickerington Eye Care	Pickerington	Ohio
United States	Lone Star Vision Center	Plano	Texas
United States	Child & Family Eye Care Center	Pleasant Grove	Utah
United States	Redmond Eye Clinic	Redmond	Washington
United States	All Eyes on Rockville	Rockville	Maryland
United States	Dau Family Eye Care	Saint Johns	Florida
United States	Broadway Eye Clinic	Salt Lake City	Utah
United States	Stone Oak Vision Source	San Antonio	Texas
United States	Almaden Family Optometric Center	San Jose	California
United States	Perfect Pair Optometry	San Jose	California
United States	Invision Eye Health	Sandy	Utah
United States	Nittany Eye Associates, LLC	State College	Pennsylvania
United States	Wellesley Vision Group at Optical Design	Wellesley	Massachusetts
United States	Colonial Eye Care	Williamsburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Microbial Keratitis (MK)	Incidence of Microbial Keratitis (MK) = 1 mm	3 years
Secondary	Incidence of peripheral infiltrative keratitis/non-infectious ulcers	Incidence of peripheral infiltrative keratitis/non-infectious ulcers = 1 mm	3 years
Secondary	Incidence of non-infectious infiltrative keratitis	Incidence of non-infectious infiltrative keratitis = 1 mm	3 years
Secondary	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