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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
CooperVision, Inc.
Study ID
NCT05285553
Status
Recruiting
Apply to this trial

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • MiSight 1 Day — DEVICE
    Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
  • Proclear 1 day — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 25, 2022
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MiSight 1 day
    MiSight 1 day
  • Active Comparator: Proclear 1 day
    Proclear 1 day

Primary Outcome Measure

Mean difference in cycloplegic SERE change from baseline [ Time Frame: 3 years ]

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
University of Alabama School of OptometryBirminghamAlabama35233
Natalie West, O.D.
Marshall B. Ketchum University Southern California College of OptometryFullertonCalifornia92831
Erin Tomiyama, O.D., Ph.D.
Vision Solutions Optometry IncLa MesaCalifornia91942
Jamie Peters, O.D.
Paje OptometricSanta AnaCalifornia92704
Vanessa Grichine, O.D.
Coan Eye Care and Optical BoutiqueOcoeeFlorida34761
Roxanne Achong-Coan, O.D.
West Broward Eyecare AssociatesTamaracFlorida33321
Brianna Rhue, O.D.
Bright Eyes Family Vision CareTampaFlorida33626
Nathan Bonilla-Warford, O.D.
Illinois College of OptometryChicagoIllinois60616
Yi Pang, OD, PhD
SoLo Eye Care & Eyewear GalleryChicagoIllinois60608
Katarzyna Aleszczyk, O.D.
Chicago College of OptometryDowners GroveIllinois60515
Vakishan Nadarajah, O.D.
Carillon Vision CareGlenviewIllinois60025
Andrew Neukirch, O.D.
Brain Vision InstituteSchaumburgIllinois60194
Ingryd Lorenzana, O.D.
Clinical Optics Research Lab at IU School of OptometryBloomingtonIndiana47406
Peter Kollbaum, O.D.
Kannarr Eye CarePittsburgKansas66762
Shane Kannarr, O.D.
New England College of OptometryBostonMassachusetts02115
Anh Bui, O.D.
Cornea and Contact Lens InstituteEdinaMinnesota55436
Zachary Holland, O.D.
Vision Source EyeCareKansas CityMissouri64111
Ryan Powell, O.D.
Athens Eye CareAthensOhio45701
Shane Foster, O.D.
Ohio State UniversityColumbusOhio43210
Jennifer Fogt, O.D.
ProCare Vision Center, Inc.GranvilleOhio43023
Katherine Bickle, O.D.
Miamisburg Vision CareMiamisburgOhio45342
Keith Basinger, O.D.
Eye Care ProfessionalsPowellOhio43065
Jason Miller, O.D.
Southern College of OptometryMemphisTennessee38104
Morgan Ollinger, O.D.
Texas State OpticalBeaumontTexas77706
Samir N Patel, O.D.
University of Houston College of OptometryHoustonTexas77204
Eric Ritchey, O.D.
Vision One EyecareKatyTexas77450
Lawrence Wong, O.D.
Lone Star VisionPlanoTexas75024
Paola Diaz, O.D.
Utah Eye CentersOgdenUtah84403
Michael Bullard, M.D.
Virginia Pediatric Eye CareChesapeakeVirginia23320
Stacy Martinson, O.D.
Factoria Eye ClinicBellevueWashington98006
Caroline Kaufman, O.D.

Find similar trials in Birmingham, AL

By research site
University of Alabama School of Optometry· Birmingham, ALMarshall B. Ketchum University Southern California College of Optometry· Fullerton, CAVision Solutions Optometry Inc· La Mesa, CAPaje Optometric· Santa Ana, CACoan Eye Care and Optical Boutique· Ocoee, FLWest Broward Eyecare Associates· Tamarac, FL

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