Myopia control with two novel soft contact lenses in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-masked trial, children will be assigned to Lens A, Lens B, or single-vision lenses for 12 months. After 12 months, the single-vision group switches to Lens A and all participants continue wearing lenses for another year, with measurements every 6 months over 2 years. The study tracks cycloplegic refraction and axial length to assess myopia control performance. The trial is conducted at the Optometry Research Clinic of The Hong Kong Polytechnic University, with collaboration from Eyebright Medical Technology. Eligibility focuses on schoolchildren in Hong Kong who meet predefined refractive and ocular health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Age at enrolment: 7 - 12 (both inclusive) years old Hong Kong Chinese schoolchildren

  * Refractive errors in terms of spherical equivalent refraction (SER) determined by cycloplegic autorefraction: -0.75 diopters (D) to -5.00D in both eyes
  * Astigmatism: equal or less than -1.00D
  * Anisometropia: equal or less than -1.75D
  * Previous myopia progression:

    * -0.50D (in SER) per year or more in 1 eye or both eyes OR Axial length elongation: 0.27mm/year in 1 eye or both eyes
    * If myopia is initially detected during screening, eligibility requires an SER below the 3rd percentile curve of refraction in either or both eyes (4)
  * Best corrected visual acuity: better than 0.04 LogMAR in both eyes
  * Ocular health: no abnormalities in both internal and external ocular health
  * Systemic health: no systemic interference with ocular vision functioning
  * Binocular vision: no strabismus and other binocular abnormalities
  * No medication or supplements that affect eye growth
  * Normal colour vision
  * No previous use of myopic control interventions such as red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control
  * Agree to maintain the visit schedule and be able to keep all appointments as specified in the informed assent and consent forms throughout study duration.
  * Agree to accept either the control or study lens as assigned by the randomization scheme
  * Agree to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 2-year study and to inform the study investigator if this schedule is interrupted. Wearing time may be modified by the study staff for health reasons
  * Agree to adhere to contact lens use requirements throughout study duration
  * Acceptance of the masked study design

Exclusion Criteria:

* Contraindications for soft contact lenses
* Dry eye with drug intervention within 30 days

  * Regular use of ocular medication (prescription or over-the-counter), artificial tears, or wetting agents due to dryness, allergies or other conditions that hinder the contact lens wear
  * Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, accommodation, or refractive state. These include, but not limited to, long term use of nasal decongestants (e.g., pseudoephedrine, phenylephrine), antihistamines (e.g., chlorpheniramine, diphenhydramine, Prednisolone or Ritalin (methylphenidate)
  * Pre-existing systemic and ocular disease that had an influence on contact lens wearing
  * History of ocular injury or surgery
  * Prior use of myopic control interventions such as red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements
  * Allergy to cyclopentolate eye drops
  * Subjects who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination

Where it's running

• Optometry Research Clinic, School of Optometry, The Hong Kong Polytechnic University
  Kowloon, Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Rachel Ka Man Chun, PhD — School of Optometry, The Hong Kong Polytechnic University
• Study coordinator: Rachel Ka Man Chun, PhD
• Email: rachel.chun@polyu.edu.hk
• Phone: 852-27664224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.