NCT05285553 MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
| NCT ID | NCT05285553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CooperVision, Inc. |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2022-06-25 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2022-06-25 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Contact & Investigator
William Gleason, OD
PRINCIPAL INVESTIGATOR
Foresight Regulatory Strategies, Inc. (FRS)
Frequently Asked Questions
Who can join the NCT05285553 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05285553 currently recruiting?
Yes, NCT05285553 is actively recruiting participants. Contact the research team at MiSight.EfficacyPAS@coopervision.com for enrollment information.
Where is the NCT05285553 trial being conducted?
This trial is being conducted at Birmingham, United States, Fullerton, United States, La Mesa, United States, Santa Ana, United States and 11 additional locations.
Who is sponsoring the NCT05285553 clinical trial?
NCT05285553 is sponsored by CooperVision, Inc.. The principal investigator is William Gleason, OD at Foresight Regulatory Strategies, Inc. (FRS). The trial plans to enroll 900 participants.