MyopiaEVASIONNCT07683481
Comparing Myopia Control Spectacle Lenses for Visual Comfort, Adaptation, and Satisfaction in Myopic Children
A study testing HADAL Spectacle Lenses and Stellest® Spectacle Lenses in people with Myopia, run by Essilor International.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- HADAL Spectacle Lenses and Stellest® Spectacle Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Volunteer participant who is willing and able to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
- Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
- Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye.
- Be in good general health, based on the participant and the parent's/guardian's knowledge.
Who cannot join
- History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- History of ocular injury or surgery.
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- Participation in any clinical study within 30 days of the Baseline visit.
- Sibling of existing participant of this study
- Study participants deemed inappropriate for the study by the investigator.
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Thomas Boudenne contact
About this study
Official title: Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children
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?
Read more
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:
- Wear the study spectacles for 2 weeks
- Respond to questionnaires 4 days after dispensing and at 2 weeks
- Visit Essilor R\&D Centre for screening, dispensing and follow up sessions
- Conditions
- Myopia
- Being tested
- HADAL Spectacle Lenses, Stellest® Spectacle Lenses
- Keywords
- adaptation, visual comfort, satisfaction, refractive error
- Medical subject headings
- Myopia, Personal Satisfaction, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HADAL Spectacle LensesDevice
Dispense to Test group for 2 weeks
Stellest® Spectacle LensesDevice
Dispense to Control group for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Test Lens Receives: Device: HADAL Spectacle Lenses |
| Control | Active comparator | Control Lens Receives: Device: Stellest® Spectacle Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Adaptation Rate Within 1 Week After Dispensing
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.
Measured: Within 1 week post dispensing
Secondary outcomes (5)
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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At dispensing (baseline) and 2 weeks post-dispensing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheron Quak, Principal investigator, Essilor R&D Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683481
- Sponsor's protocol ID
- WS10506
- Other IDs
- PIEC/2026/015
- Acronym
- EVASION
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Comfort, Adaptation, and Satisfaction With a Myopia Control Lens in Myopic Children
- ClinicalTrials.gov ID
- NCT07683481
- Acronym / sponsor ID
- EVASION / WS10506
- Conditions
- Myopia
- Keywords
- adaptation, visual comfort, satisfaction, refractive error
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Wear the study spectacles for 2 weeks
- Respond to questionnaires 4 days after dispensing and at 2 weeks
- Visit Essilor R\&D Centre for screening, dispensing and follow up sessions
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: HADAL Spectacle LensesTest Lens |
| Control | Active comparator | Device: Stellest® Spectacle LensesControl Lens |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Volunteer participant who is willing and able to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age ≥ 6 years and < 11 years at the time of signing informed consent and assent.
- Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes.
- Difference in SER (anisometropia) between two eyes should not exceed 1.50 D.
Key exclusion criteria (10 listed)
- History of Atropine, Orthokeratology, Contact Lens or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HADAL Spectacle LensesDispense to Test group for 2 weeks | Device | Test |
| Stellest® Spectacle LensesDispense to Control group for 2 weeks | Device | Control |
Primary outcome
Successful Adaptation Rate Within 1 Week After Dispensing
Time frame: Within 1 week post 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.
5 secondary outcomes
Successful Adaptation Rates at Early and Later Timepoints
Time frame: 4 days and 2 weeks post-dispensing
Average daily and weekly wearing time
Time frame: Assessed at Day 4 and Week 2 post-dispensing
Activity-specific visual comfort
Time frame: 4 days and 2 weeks post-dispensing
Overall satisfaction
Time frame: 4 days and 2 weeks post-dispensing
High-contrast visual acuity (distance and near)
Time frame: At dispensing (baseline) and 2 weeks post-dispensing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Boudenne contact
Sheron Quak principal investigator
Essilor R&D Centre Singapore
Questions about this trial
What is this clinical trial studying?
A study testing HADAL Spectacle Lenses and Stellest® Spectacle Lenses in people with Myopia, run by Essilor International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celine Carimalo (+65 67134617, carimalc@essilor.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Adaptation Rate Within 1 Week After Dispensing (time frame: Within 1 week post dispensing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.