Kannarr Eye Care | Kannarr Eye Care - Pittsburg, KS
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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.
Full 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.
Enrollment
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Inclusion criteria
Exclusion criteria
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.
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.
Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:
Has history of:
Keratoconus or an irregular cornea.
Strabismus or amblyopia.
Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
Primary purpose
Allocation
Interventional model
Masking
900 participants in 2 patient groups
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Central trial contact
Kathryn Richdale, OD, PhD
Data sourced from clinicaltrials.gov
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