An interventional study of HADAL Spectacle Lenses and Stellest® Spectacle Lenses in Myopia, sponsored by Essilor International. Not yet recruiting. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Essilor International · Not applicable, Interventional, and Supportive care
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:
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 20 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test Lens
Device: HADAL Spectacle Lenses
Control Lens
Device: Stellest® Spectacle Lenses
Dispense to Test group for 2 weeks
Dispense to Control group for 2 weeks
Successful Adaptation Rate Within 1 Week After Dispensing
Proportion of children who meet all of the following criteria at the 1-week visit: 1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire 2. 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 3. 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.
Time frame: Within 1 week post dispensing
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: 1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire 2. 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 3. 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At dispensing (baseline) and 2 weeks post-dispensing
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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