Myopia Control Using Novel Soft Contact Lenses

Advancing Myopia Control in Children: A Randomized Controlled Trial of Two Novel Daily Disposable Contact Lenses

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Other: Lens A; Other: Lens B

Detailed Description

This is a double-masked and randomized controlled trial. Participants will be randomly assigned to one of three interventions: two study contact lenses (CL)(Lens A or Lens B) or single vision (SVCL) for the initial 12 months. While the Lens A/B groups will continue their respective lenses, the participants initially assigned to the SVCL will cross over to Lens A at the 12-month mark. 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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dennis Yan Yin Tse, PhD; Phone Number: 852-27666096; Email: dennis.tse@polyu.edu.hk
• Study Contact Backup: Name: Rachel Ka Man Chun, PhD; Phone Number: 852-27664224; Email: rachel.chun@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Lens A; Lens A contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.
Experimental: Lens B group; Participants in Lens B group will receive Lens B contact lenses for 24 months.	Other: Lens B; Lens B contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycloplegic refraction change in spherical equivalent refraction (SER)	Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 2 years over the study period.	Baseline, 6, 12, 18 and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length changes	Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 2 year over the study period.	Baseline, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Eyebright Medical Technology (Beijing) Co., Ltd.
• Investigators: Principal Investigator: Rachel Ka Man Chun, PhD, School of Optometry, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): July 14, 2029

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: soft contact lenses; Myopia control
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; CRYAB protein, human
• Other Study ID Numbers: P0059974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No