Actively Recruiting
MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms in Children with Myopia
Led by CooperVision, Inc. · Updated on 2025-08-17
900
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the MiSight 1 Day contact lens in slowing the progression of myopia in children aged 8 to 12 years in the United States. This multicenter, randomized, double-masked clinical trial lasts four years and aims to confirm the lens's ability to reduce myopia and assess the stability of this effect one year after treatment ends. The study is sponsored by CooperVision, Inc. Participants are randomly assigned to wear either MiSight 1 Day lenses or Proclear 1 day lenses for three years in Part 1 of the study. In Part 2, all participants will wear Proclear 1 day lenses for one year to evaluate the stability of myopia control after discontinuing MiSight lenses. Both subjects and investigators remain unaware of the lens assignments throughout the trial. During the study, participants will undergo regular eye exams including measurements of refractive error and axial length to monitor changes in myopia. Researchers will also assess visual symptoms and how these affect daily activities. The trial includes adherence to lens wear for about 10 hours daily, six days a week, and requires participants to attend scheduled visits for up to four years. Safety and effectiveness data will be collected throughout the study period.
CONDITIONS
Brief Title
MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent and assent completed
- Aged between 8 and 12 years inclusive at enrollment
- Spherical Equivalent Refractive Error (SERE) between -0.75 D and -4.00 D at baseline in each eye
- Best-corrected visual acuity of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye
- Anisometropia of 1.50 D SERE or less
- Astigmatism of 0.75 D or less
- Free of ocular disease or abnormalities including corneal scars
- Good general health
- Agree to accept lens assignment by randomization
- Capable of understanding the study and willing to follow study instructions
- Able to comply with study procedures including vision and eye measurements
- Able to maintain scheduled visits
- Willing to participate for 4 years
- Interested in wearing contact lenses about 10 hours per day, 6 days per week
- Possesses or obtains wearable and functional eyeglasses (20/40 or better)
You will not qualify if you...
- Current or prior use of myopia control treatments such as bifocals, progressive lenses, orthokeratology, atropine, or similar
- Use of systemic or ocular medications or artificial tears that interfere with contact lens wear or eye measurements
- Previous or current use of rigid gas permeable contact lenses including orthokeratology
- Contraindications to MiSight 1 Day lenses such as eye inflammation, infections, corneal or eyelid diseases, severe dry eyes, corneal hypoesthesia (unless aphakic), systemic diseases affecting eyes, allergic reactions related to contact lenses or solutions, active corneal infections, red or irritated eyes, or inability to follow lens care instructions
- History of corneal ulcers, infiltrates, viral or fungal eye infections, recurrent ocular infections, giant papillary conjunctivitis, or allergic reactions to fluorescein or topical anesthetics
- Keratoconus or irregular cornea
- Strabismus or amblyopia
- Any systemic disease that may affect the eye or be worsened by contact lens wear
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants wear either MiSight 1 Day lenses or Proclear 1 day lenses to study effectiveness in slowing myopia progression.
Regular visits for eye and vision assessments during the 3-year treatment period
Duration - 1 year
Participants wear Proclear 1 day lenses to study stability of effectiveness after treatment ends.
Regular visits for assessments during the 1-year post-treatment period
Trial Site Locations
Total: 30 locations
1
University of Alabama School of Optometry
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Marshall B. Ketchum University Southern California College of Optometry
Fullerton, California, United States, 92831
Actively Recruiting
3
Vision Solutions Optometry Inc
La Mesa, California, United States, 91942
Actively Recruiting
4
Paje Optometric
Santa Ana, California, United States, 92704
Actively Recruiting
5
Coan Eye Care and Optical Boutique
Ocoee, Florida, United States, 34761
Actively Recruiting
6
West Broward Eyecare Associates
Tamarac, Florida, United States, 33321
Actively Recruiting
7
Bright Eyes Family Vision Care
Tampa, Florida, United States, 33626
Actively Recruiting
8
SoLo Eye Care & Eyewear Gallery
Chicago, Illinois, United States, 60608
Actively Recruiting
9
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Actively Recruiting
10
Chicago College of Optometry
Downers Grove, Illinois, United States, 60515
Actively Recruiting
11
Carillon Vision Care
Glenview, Illinois, United States, 60025
Actively Recruiting
12
Brain Vision Institute
Schaumburg, Illinois, United States, 60194
Actively Recruiting
13
Clinical Optics Research Lab at IU School of Optometry
Bloomington, Indiana, United States, 47406
Actively Recruiting
14
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
Actively Recruiting
15
New England College of Optometry
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
Cornea and Contact Lens Institute
Edina, Minnesota, United States, 55436
Actively Recruiting
17
Vision Source EyeCare
Kansas City, Missouri, United States, 64111
Actively Recruiting
18
Athens Eye Care
Athens, Ohio, United States, 45701
Actively Recruiting
19
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
20
ProCare Vision Center, Inc.
Granville, Ohio, United States, 43023
Actively Recruiting
21
Miamisburg Vision Care
Miamisburg, Ohio, United States, 45342
Actively Recruiting
22
Eye Care Professionals
Powell, Ohio, United States, 43065
Actively Recruiting
23
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
24
Texas State Optical
Beaumont, Texas, United States, 77706
Actively Recruiting
25
University of Houston College of Optometry
Houston, Texas, United States, 77204
Actively Recruiting
26
Vision One Eyecare
Katy, Texas, United States, 77450
Actively Recruiting
27
Lone Star Vision
Plano, Texas, United States, 75024
Actively Recruiting
28
Utah Eye Centers
Ogden, Utah, United States, 84403
Actively Recruiting
29
Virginia Pediatric Eye Care
Chesapeake, Virginia, United States, 23320
Actively Recruiting
30
Factoria Eye Clinic
Bellevue, Washington, United States, 98006
Actively Recruiting
Research Team
K
Kathryn Richdale, OD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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