Twelve-Month Outcomes in Children Using MiSight® 1-Day Contact Lenses and Myopia Control Spectacle Lenses as Complementary Myopia Control Interventions.
| Registry | NCT07845721 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 58 (Estimated) |
| Sponsor | CooperVision International Limited (CVIL) (Industry); collaborators: SightGlass Vision, Inc. |
| Conditions | Myopia |
| Interventions | Test Spectacle Lens & Contact Lens, Control Spectacle Lens & Contact Lens (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2028-02-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-09-29, last updated 2026-09-29 |
| Locations | 2 sites in Canada, United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Myopia All trials of Test Spectacle Lens & Contact Lens All trials of Control Spectacle Lens & Contact Lens
Effect of alternating contact lenses and spectacles for myopia control.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test Group | Experimental | Device: Test Spectacle Lens & Contact Lens | Participants will wear Test Spectacle Lens \& Contact Lenses |
| Control Group | Experimental | Device: Control Spectacle Lens & Contact Lens | Participants will wear Control Spectacle Lens \& Contact Lenses |
Sex: All, ages: 11 Years to 17 Years
Inclusion Criteria: * Are aged 11 to 17 years (inclusive); * Have successfully completed the 4-year MiSight® Analysis of Progression (MAP) Study; * Are established soft contact lens wearers (including myopia control contact lens designs); * Have read and signed the study consent or assent form, as appropriate for their age; * Have a parent or legal guardian who has read and signed the Parent/Guardian Information Sheet (PIS) and Consent Form; * Are willing and able to follow study instructions and maintain the appointment schedule; * Are willing to wear the study contact lenses for 10 hours/day and 5 days per week as an ideal target while participating; * Require a spherical contact lens power correction between -0.50 and -6.00 D; * Have astigmatism not exceeding 2.00 DC in each eye by subjective refraction; * Have best-corrected visual acuity of 0.10 logMAR (approx. 20/25 Snellen) or better in each eye; * Have ocular health findings (biomicroscopy) that do not contraindicate contact lens wear; * Continue to demonstrate acceptable fit and handling with the study contact lenses. Exclusion Criteria: * Are participating in any concurrent clinical or interventional study; * Have worn rigid gas-permeable (including orthokeratology) contact lenses within the previous 30 days; * Have used atropine concentrations above 0.01% for myopia control in the previous 30 days; * Are extended-wear contact lens users (i.e., sleep in their lenses); * Have best-corrected visual acuity worse than 0.10 logMAR in either eye; * Have any current or evolving ocular or systemic condition that could affect visual function, ocular growth, or contact lens wear; * Have any clinically significant corneal or conjunctival staining with sodium fluorescein, or other ocular findings contraindicating contact lens wear; * Are using systemic or topical medications known or expected to affect pupil size, tear production, accommodation, refractive state, or any study outcome variable; * Have a history of ocular surgery, keratoconus, or other forms of irregular cornea, or are aphakic; * Have diagnosed accommodative and/or binocular vision anomalies, including amblyopia, strabismus, or nystagmus; * Have known sensitivity or allergy to any of the diagnostic agents used in the study; * Have any systemic condition that, in the opinion of the investigator, may influence study outcomes or contraindicate soft contact lens wear, including pregnancy; * Are a child of an employee of either clinical site directly involved in the study.
| Facility | City | Country | Status |
|---|---|---|---|
| Centre for Ocular Research & Education (CORE) School of Optometry & Vision Science University of Waterloo | Waterloo, Ontario | Canada | |
| Aston University | Birmingham | United Kingdom |