Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial

Inclusion criteria

• Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
• Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
• The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.

• Based on the slit-lamp examination results of the screening clinic, determined that the infection of the conjunctiva, eyelids and accessory organs was less than Grade 2 (mild).
• No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
• Slit lamp findings must be less than Grade 1 (mild) and the cornea must not show: edema, staining, clouding, or vascularization according to the slit lamp findings of the screening clinic.
• No iritis.
• There are no other active eye diseases that are not suitable for contact lens wear.
• No topical eye drops are currently being used.
• The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
• Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
• Meet the following refractive criteria determined by cycloplegic autorefraction at baseline

• Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
• Astigmatism: ≤-0.75 D
• Anisometropia: <1.00 D

Exclusion criteria

• Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
• Those who are unable to comply with regular tracking and inspection.
• Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
• Subject has undergone any eye surgery or corneal surgery.
• Subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry.
• Those who are unable to cooperate with regular tracking and inspection.
• Participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.