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| ID | Type | Description | Link |
|---|---|---|---|
| PIEC/2026/015 | Registry Identifier | Parkway Independent Ethics Committee |
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The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and < 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is:
Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints?
Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period?
Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Test Lens |
|
| Control | Active Comparator | Control Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HADAL Spectacle Lenses | Device | Dispense to Test group for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Adaptation Rate Within 1 Week After Dispensing | Proportion of children who meet all of the following criteria at 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. | Within 1 week post dispensing |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Adaptation Rates at Early and Later Timepoints | Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing:
Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celine Carimalo | Contact | +65 67134617 | carimalc@essilor.com.sg | |
| Thomas Boudenne | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Sheron Quak | Essilor R&D Centre Singapore | Principal Investigator |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D010549 | Personal Satisfaction |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D001519 | Behavior |
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This is a prospective, parallel-group, monocentre, non-inferiority clinical comparing test lenses with control lenses during which 20 myopic children aged ≥ 6 years and < 11 years will be enrolled and randomized 1:1 to test group or control group as participants, for a period of 2 weeks.
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| Stellest® Spectacle Lenses |
| Device |
Dispense to Control group for 2 weeks |
|
| 4 days and 2 weeks post-dispensing |
| Average daily and weekly wearing time | 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. | Assessed at Day 4 and Week 2 post-dispensing |
| Activity-specific visual comfort | 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. | 4 days and 2 weeks post-dispensing |
| Overall satisfaction | 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. | 4 days and 2 weeks post-dispensing |
| High-contrast visual acuity (distance and near) | 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. | At dispensing (baseline) and 2 weeks post-dispensing |