MiSight 1 Day Safety Post-Approval Study
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Be between 8 and 12 years of age inclusive at the time of enrollment.
- Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
- Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
- Free of ocular disease or abnormalities (including any corneal scar)
- 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.
- Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
- Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
- Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
EXCLUSION CRITERIA
Exclusion Criteria:
- Acute and subacute inflammation or infection of the anterior chamber of the eye.
- Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
- Severe insufficiency of lacrimal secretion (dry eyes).
- Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
- Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
- Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
- Any active corneal infection (bacterial, fungal, or viral).
- If eyes are red or irritated.
- The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
- In addition to the labeling contraindications, children who are under medication that would interfere with contact lens wear, or who are using any pharmaceuticals for control of myopia will not be included in the study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Myopia
Age
8+
Phase
NA
Participants Needed
2400
Est. Completion Date
May 30, 2027
Treatment Type
INTERVENTIONAL
Sponsor
CooperVision International Limited (CVIL)
ClinicalTrials.gov NCT Identifier
NCT05285527
Study Number
PAS002
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