Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children

Proportion of children who meet all of the following criteria at the 1-week visit:

• Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire
• Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the 4-day visit, as assessed through the symptom checklist in the study questionnaire
• No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the 1-week visit.

Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin.

Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing:

• Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire
• Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the previous visit, as assessed through the symptom checklist in the study questionnaire
• No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the respective visit

Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints.

Mean daily wearing time (hours/day) and total weekly wearing time (hours/week) of the assigned study spectacles will be compared between the test and control groups, based on participant/parent-reported wear time.

Participant-reported visual comfort during daily activities (including far vision, intermediate vision, near vision with and without digital devices, and overall vision) will be evaluated using the specific comfort subscale items from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual comfort items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded comfort questions are reverse-coded prior to analysis so that all values are directionally aligned. The subscale score is calculated as the mean of these items, yielding a minimum value of 1 and a maximum value of 4, where a higher score indicates a better outcome (greater visual comfort during daily activities). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.

Overall satisfaction with the study spectacles will be evaluated using the satisfaction subscale items (e.g., "I hate wearing the new spectacles" and "I like my new spectacles") from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded items are reverse-coded during data analysis. Subscale scores are calculated as the mean of the items, ranging from a minimum value of 1 to a maximum value of 4, where higher scores indicate a better outcome (higher satisfaction with the spectacles). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint.

Monocular and binocular high-contrast visual acuity at distance and near, measured while wearing study spectacles, will be compared between the test and control groups.