Myopia Control Using Novel Soft Contact Lenses

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07547085
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
7 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Lens A — OTHER
    Lens A contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.
  • Lens B — OTHER
    Lens B contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.

Study Details

The goal of this study is to investigate the myopic control efficacy of two study soft contact lenses in children. Participants will be prescribed Lens A, Lens B or single vision contact lenses for the first year. Participants in single vision contact lenses group will switch to Lens A at 12 months. All participants will then continue lens wear for an additional 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months for 2 years.

Key Dates

First listed
Apr 23, 2026
Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Jul 14, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Single vision lens group
    Participants in single vision contact lens group will receive single vision contact lenses for initial 12 months. They will switch to Lens A at 12-month mark for an additional 12 months.
  • Experimental: Lens A group
    Participants in Lens A group will receive Lens A contact lenses for 24 months.
  • Experimental: Lens B group
    Participants in Lens B group will receive Lens B contact lenses for 24 months.

Primary Outcome Measure

Cycloplegic refraction change in spherical equivalent refraction (SER) [ Time Frame: Baseline, 6, 12, 18 and 24 months ]

Central Contacts

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