This study will enroll 63 eligible subjects (126 eligible eyes, complete at least 108 evaluable eyes) in approximately 6 different medical centers in Taiwan, in order to evaluate the efficacy and safety of ST-1 silicone hydrogel daily disposable soft contact lenses (ST-1 lenses) compared to Miru 1day UpSide. Enrolled subjects will be randomized in a 2:1 test to control ratio at Visit 1. Each site will enroll 8 (intended minimum) to 12 (intended maximum) subjects. In order to eliminate the bias, the Investigators and the evaluators will be masked to the treatment assignment of the randomization code. During the study, the Investigator(s) will examine the ocular health via inquiry, slit lamp biomicroscopy (SLB), visual acuity (VA) test, keratometry, and refractive changes. The Investigator(s) will check ocular health and evaluate the inclusion/exclusion criteria of subjects at screening. After entering the study, subjects will be required to wear the lenses on a daily basis, record daily wearing time on a diary, return to the study site at scheduled visits for evaluations and complete the self-assessment questionnaire at Visit 2 to Visit 7 (1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months).
With either gender aged between 18 to 40 (inclusive) years old.
Diagnosis of myopia in both eyes, each ranging from -0.50D to 6.00D with manifest astigmatism of ≤ 1.00D per eye.
Understands and signs an informed consent form (ICF).
Willing to adhere to the instructions set forth in this study as well as understand and complete all specified evaluation.
Evidence of lid abnormality or infection (e.g., entropion, ectropion, chalazia, and recurrent styes).
Clinically significant slit lamp findings (e.g., infiltrates or other slit lamp findings Level 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
Other active ocular disease (e.g., uveitis, corneal epithelial defect, severe dry eye, lacrimal duct defect, glaucoma, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
History of recurrent corneal erosions.
Parallel
ST-1
DeviceST-1 lens worn in daily wear, daily disposable mode.
Miru 1day UpSide
DeviceMiru 1day UpSide lens worn in daily wear, daily disposable mode.
Corrected distance Logarithm of the Minimum Angle of Resolution (logMAR) visual acuity at the final visit (Visit 7)
Assessed using a Tumbling E Series ETDRS® chart.
Self-assessment of eye symptoms
This questionnaire includes 11 items assessing symptoms during contact lens wear: discomfort, tearing, photophobia, itching, burning, halos, dryness, variable vision, blurred vision, pain, and other (specify if present). Scale: 0-4 (minimum = 0, maximum = 4), where higher scores indicate worse symptoms. Grades: 0 = None 1. = Trace 2. = Mild 3. = Moderate 4. = Severe
Self-assessment of lens performance
This questionnaire includes 5 items assessing lens performance during contact lens wear: insertion comfort, overall comfort, vision, insertion handling, and removal handling. Scale: 0-5 (minimum = 0, maximum = 5), where higher scores indicate worse performance. Grades: 【comfort】 0 = Excellent 1 = Very comfortable 2 = Comfortable 3 = Slightly uncomfortable 4 = Very uncomfortable 5 = Causes pain 【vision】 0 = Excellent 1. = Very good 2. = Good 3. = Poor 4. = Very poor 5. = Unacceptable 【handling】 0 = Excellent 1. = Very good 2. = Good 3. = Poor 4. = Very poor 5. = Unmanageable
Total wearing hours
Cumulative duration of lens wear throughout the study period, determined from the daily wearing time recorded by participants in the electronic patient-reported outcome (ePRO) diary.
Total wearing days
Total number of days the study lenses were worn for 8 hours or more, based on the daily wearing time entered by participants in the electronic patient-reported outcome (ePRO) diary. A wearing day is defined as a day with 8 hours or more of lens wear.
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