MiSight 1 Day Safety Post-Approval Study
Study Details
Study Description
Brief Summary
The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MiSight 1 Day MiSight Day |
Device: MiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Microbial Keratitis (MK) [3 years]
Incidence of Microbial Keratitis (MK) ≥ 1 mm
Secondary Outcome Measures
- Incidence of peripheral infiltrative keratitis/non-infectious ulcers [3 years]
Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm
- Incidence of non-infectious infiltrative keratitis [3 years]
Incidence of non-infectious infiltrative keratitis ≤ 1 mm
- Incidence of loss of best-corrected visual acuity [3 years]
Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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 at least 20/25 bilaterally
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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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The parent/guardian must be capable of comprehending the nature of the study and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this study. Assent will be obtained from the child in a manner specified by the IRB.
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Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
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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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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: William Gleason, OD, Foresight Regulatory Strategies
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PAS002