Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Informed Consent and Assent have been completed
- 2. Be between 8 and 12 years of age inclusive at the time of enrollment.
- 3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye
- 4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
- 5. Anisometropia: ≤ 1.50D SERE.
- 6. Astigmatism: ≤ 0.75 D
- 7. Free of ocular disease or abnormalities (including any corneal scar)
- 8. Currently have good general health.
- 9. Agree to accept the lens as assigned by the randomization.
- 10. Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
- 11. Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes.
- 12. Able to maintain the visit schedule.
- 13. Willingness to participate in the trial for 4 years.
- 14. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
- 15. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
- 1. 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.
- 2. 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.
- 3. Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
- 4. Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:
- * 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.
- 5. Has history of:
- * Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
- * Giant papillary conjunctivitis
- * Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses
- * A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
- * Corneal hypoesthesia (reduced corneal sensitivity)
- 6. Keratoconus or an irregular cornea.
- 7. Strabismus or amblyopia.
- 8. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
Ages Eligible for Study
8 Years to 12 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes