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

NCT07683481 | Not Yet Recruiting

• 2 other identifiers: WS10506PIEC/2026/015
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Myopia

Keywords

adaptation; visual comfort; satisfaction; refractive error

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 week post dispensing

Secondary Outcomes (5)

• Successful Adaptation Rates at Early and Later Timepoints

  4 days and 2 weeks post-dispensing

• Average daily and weekly wearing time

  Assessed at Day 4 and Week 2 post-dispensing

• Activity-specific visual comfort

  4 days and 2 weeks post-dispensing

• Overall satisfaction

  4 days and 2 weeks post-dispensing

• High-contrast visual acuity (distance and near)

  At dispensing (baseline) and 2 weeks post-dispensing

Study Arms (2)

Test

EXPERIMENTAL

Test Lens

Device: HADAL Spectacle Lenses

Control

ACTIVE COMPARATOR

Control Lens

Device: Stellest® Spectacle Lenses

Interventions

HADAL Spectacle Lenses DEVICE

Dispense to Test group for 2 weeks

Test

Stellest® Spectacle Lenses DEVICE

Dispense to Control group for 2 weeks

Control

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Essilor International: lead

MeSH Terms

Conditions

Myopia; Personal Satisfaction; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases; Behavior

Study Officials

• Sheron Quak

  Essilor R&D Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Carimalo

CONTACT

+65 67134617; carimalc@essilor.com.sg

Thomas Boudenne

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share