Clinical trial NCT05285527: MiSight 1 Day Safety Post-Approval Study
Official title: MiSight 1 Day Safety Post-Approval Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 2400
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Microbial Keratitis (MK)
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of peripheral infiltrative keratitis/non-infectious ulcers
timeFrame: 3 years
measure: Incidence of non-infectious infiltrative keratitis
timeFrame: 3 years
measure: Incidence of loss of best-corrected visual acuity
timeFrame: 3 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Experts on Sight LLC.
state: Arizona
city: Centerton
country: United States
facility: Centerton Family Eyecare
state: Arkansas
city: Berkeley
country: United States
facility: University of California, Berkeley University Eye Center
state: California
city: Cupertino
country: United States
facility: Golden Vision Cupertino Optometry
state: California
city: Danville
country: United States
facility: Boghossian Vision
state: California
city: Dublin
country: United States
facility: Iron Horse Optometric Group
state: California
city: Fremont
country: United States
facility: Capitol Eye Care Center Optometry
state: California
city: Irvine
country: United States
facility: Irvine Eye Physicians and Surgeons Inc
state: California
city: Oakland
country: United States
facility: Elsa Pao OD, Inc
state: California
city: San Jose
country: United States
facility: Perfect Pair Optometry
state: California
city: San Jose
country: United States
facility: Almaden Family Optometric Center
state: California
city: Centennial
country: United States
facility: Children's Eye Physicians
state: Colorado
city: Milford
country: United States
facility: Eye Physicians & Surgeons, PC
state: Connecticut
city: Lake Worth
country: United States
facility: Planet Vision Eyecare
state: Florida
city: Miami
country: United States
facility: Marino Eye Care
state: Florida
city: Oviedo
country: United States
facility: Vision Source Oviedo, INC
state: Florida
city: Saint Johns
country: United States
facility: Dau Family Eye Care
state: Florida
city: Sarasota
country: United States
facility: Gulf Coast Eye Center
state: Florida
city: Weston
country: United States
facility: Weston Contact Lens Institute LLC
state: Florida
city: Chicago
country: United States
facility: Lurie Childrens
state: Illinois
city: Chicago
country: United States
facility: Lyons Family Eye Care P.C.
state: Illinois
city: Darien
country: United States
facility: Darien Eye Specialists
state: Illinois
city: Glenview
country: United States
facility: Carillon Vision Care
state: Illinois
city: Carmel
country: United States
facility: Little Eyes Pediatric Eye Care
state: Indiana
city: Rockville
country: United States
facility: All Eyes on Rockville
state: Maryland
city: Wellesley
country: United States
facility: Wellesley Vision Group at Optical Design
state: Massachusetts
city: California
country: United States
facility: Missouri Eye Consultants - California
state: Missouri
city: Des Peres
country: United States
facility: Center for Vision and Learning
state: Missouri
city: Morristown
country: United States
facility: Advocare Pediatric Eye Physicians
state: New Jersey
city: Bronx
country: United States
facility: Bronx Eye Associates
state: New York
city: Apex
country: United States
facility: Clarity Vision
state: North Carolina
city: Cary
country: United States
facility: Cary Family Eye Care
state: North Carolina
city: Chagrin Falls
country: United States
facility: Chagrin Valley Optometrists, Inc.
state: Ohio
city: Pickerington
country: United States
facility: Pickerington Eye Care
state: Ohio
city: State College
country: United States
facility: Nittany Eye Associates, LLC
state: Pennsylvania
city: Beaumont
country: United States
facility: Texas State Optical
state: Texas
city: Bellaire
country: United States
facility: Bellaire Family Eye Care
state: Texas
city: Corpus Christi
country: United States
facility: Drs. McIntyre, Garza, Avila and Jurica, Optometrists
state: Texas
city: Frisco
country: United States
facility: Clarkson EyeCare KIDS
state: Texas
city: Plano
country: United States
facility: Lone Star Vision Center
state: Texas
city: San Antonio
country: United States
facility: Stone Oak Vision Source
state: Texas
city: Pleasant Grove
country: United States
facility: Child & Family Eye Care Center
state: Utah
city: Salt Lake City
country: United States
facility: Broadway Eye Clinic
state: Utah
city: Sandy
country: United States
facility: Invision Eye Health
state: Utah
city: Williamsburg
country: United States
facility: Colonial Eye Care
state: Virginia
city: Redmond
country: United States
facility: Redmond Eye Clinic
state: Washington
city: Morgantown
country: United States
facility: Spectrum Optical, PLLC
state: West Virginia
city: Markham
country: Canada
facility: Dr. Kit Guan & Associates
state: Ontario
city: Oakville
country: Canada
facility: Abbey Eye Care
state: Ontario
Study officials:
affiliation: Foresight Regulatory Strategies
name: William Gleason, OD
role: PRINCIPAL_INVESTIGATOR
References: