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

Sponsor
Essilor International
Study ID
NCT07683481
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • HADAL Spectacle Lenses — DEVICE
    Dispense to Test group for 2 weeks
  • Stellest® Spectacle Lenses — DEVICE
    Dispense to Control group for 2 weeks

Study Details

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

Key Dates

First listed
Jul 6, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Test
    Test Lens
  • Active Comparator: Control
    Control Lens

Primary Outcome Measure

Successful Adaptation Rate Within 1 Week After Dispensing [ Time Frame: Within 1 week post dispensing ]

Central Contacts

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