Myopia Control Using Novel Soft Contact Lenses

NCT07547085 | Not Yet Recruiting DMC

• 1 other identifier: P0059974
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myopia

Keywords

Myopia control; soft contact lenses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Axial length changes

  Baseline, 6, 12, 18 and 24 months

Study Arms (3)

Single vision lens group

NO INTERVENTION

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.

Lens A group

EXPERIMENTAL

Participants in Lens A group will receive Lens A contact lenses for 24 months.

Other: Lens A

Lens B group

EXPERIMENTAL

Participants in Lens B group will receive Lens B contact lenses for 24 months.

Other: Lens B

Interventions

Lens A OTHER

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

Lens A group

Lens B OTHER

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

Lens B group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• D (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Eyebright Medical Technology (Beijing) Co., Ltd.: collaborator

MeSH Terms

Conditions

Myopia

Interventions

CRYAB protein, human

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Rachel Ka Man Chun, PhD

  School of Optometry, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ka Man Chun, PhD

CONTACT

852-27664224; rachel.chun@polyu.edu.hk

Dennis Yan Yin Tse, PhD

CONTACT

852-27666096; dennis.tse@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): July 14, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share