Clinical trial NCT05285553: 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
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 900
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean difference in cycloplegic SERE change from baseline
timeFrame: 3 years
measure: Mean difference in axial length change from baseline
timeFrame: 3 years
measure: Mean difference in rate of cycloplegic SERE change - Part 2 study
timeFrame: 1 year
measure: Mean difference in rate of axial length - Part 2 study
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of subjects with no appreciable myopic progression
timeFrame: 3 years
measure: Visual symptoms and the effects on activities of daily living
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama School of Optometry
state: Alabama
city: Fullerton
country: United States
facility: Marshall B. Ketchum University Southern California College of Optometry
state: California
city: La Mesa
country: United States
facility: Vision Solutions Optometry Inc
state: California
city: Santa Ana
country: United States
facility: Paje Optometric
state: California
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University (NSU) College of Optometry
state: Florida
city: Ocoee
country: United States
facility: Coan Eye Care and Optical Boutique
state: Florida
city: Tamarac
country: United States
facility: West Broward Eyecare Associates
state: Florida
city: Tampa
country: United States
facility: Bright Eyes Family Vision Care
state: Florida
city: Chicago
country: United States
facility: SoLo Eye Care & Eyewear Gallery
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Downers Grove
country: United States
facility: Chicago College of Optometry
state: Illinois
city: Glenview
country: United States
facility: Carillon Vision Care
state: Illinois
city: Schaumburg
country: United States
facility: Brain Vision Institute
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Edina
country: United States
facility: Cornea and Contact Lens Institute
state: Minnesota
city: Kansas City
country: United States
facility: Vision Source EyeCare
state: Missouri
city: Athens
country: United States
facility: Athens Eye Care
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Granville
country: United States
facility: ProCare Vision Center, Inc.
state: Ohio
city: Miamisburg
country: United States
facility: Miamisburg Vision Care
state: Ohio
city: Powell
country: United States
facility: Eye Care Professionals
state: Ohio
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Beaumont
country: United States
facility: Texas State Optical
state: Texas
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
city: Katy
country: United States
facility: Vision One Eyecare
state: Texas
city: Plano
country: United States
facility: Lone Star Vision
state: Texas
city: Ogden
country: United States
facility: Utah Eye Centers
state: Utah
city: Chesapeake
country: United States
facility: Virginia Pediatric Eye Care
state: Virginia
city: Bellevue
country: United States
facility: Factoria Eye Clinic
state: Washington
Study officials:
affiliation: Foresight Regulatory Strategies, Inc. (FRS)
name: William Gleason, OD
role: PRINCIPAL_INVESTIGATOR
References: