MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: MiSight 1 day MiSight 1 day |
Device: MiSight 1 Day
Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.
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Active Comparator: Proclear 1 day Proclear 1 day |
Device: Proclear 1 day
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.
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Outcome Measures
Primary Outcome Measures
- Mean difference in cycloplegic SERE change from baseline [3 years]
Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters
- Mean difference in axial length change from baseline [3 years]
Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters
- Mean difference in rate of cycloplegic SERE change - Part 2 study [1 year]
Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment; measured with cycloplegic auto-refraction in Diopters
- Mean difference in rate of axial length - Part 2 study [1 year]
Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment.
Secondary Outcome Measures
- Percentage of subjects with no appreciable myopic progression [3 years]
Percentage of subjects with no appreciable myopic progression (-0.25D change or less)
- Visual symptoms and the effects on activities of daily living [3 years]
Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed Consent and Assent have been completed
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Be between 8 and 12 years of age inclusive at the time of enrollment.
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Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane).
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Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
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Anisometropia: ≤ 1.50D SERE.
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Astigmatism: ≤ 0.75 D
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Free of ocular disease or abnormalities (including any corneal scar)
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Currently have good general health.
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Agree to accept the lens as assigned by the randomization.
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Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
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Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes.
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Able to maintain the visit schedule.
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Willingness to participate in the trial for 4 years.
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Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
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Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
Exclusion Criteria:
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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.
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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.
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Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
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Has any of the following specific contraindications to MiSight 1 Day lenses at
Baseline Visit:
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Acute and subacute inflammation or infection of the anterior chamber of the eye.
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Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
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Severe insufficiency of lacrimal secretion (dry eyes).
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Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
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Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
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Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
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Any active corneal infection (bacterial, fungal, or viral).
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If eyes are red or irritated.
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The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
- Has history of:
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Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
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Giant papillary conjunctivitis
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Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses
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A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
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Corneal hypoesthesia (reduced corneal sensitivity)
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Keratoconus or an irregular cornea.
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Strabismus or amblyopia.
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Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Kannarr Eye Care | Pittsburg | Kansas | United States | 66762 |
2 | New England College of Optometry | Boston | Massachusetts | United States | 02115 |
3 | Cornea & Contact Lens Institute of Minnesota | Edina | Minnesota | United States | 55436 |
4 | Shane Foster & Associates (Athens Eye Care) | Athens | Ohio | United States | 45701 |
5 | ProCare Vision Center | Granville | Ohio | United States | 43023 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: William Gleason, OD, Foresight Regulatory Strategies, Inc. (FRS)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PAS001/BC