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RecruitingNCT07547085Updated Sep 17, 2026

Myopia Control Using Novel Soft Contact Lenses

An interventional study of Lens A and Lens B in Myopia, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myopia

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Keywords

  • Myopia control
  • soft contact lenses
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 126 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Browse The Hong Kong Polytechnic University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
126 participants (estimated)

Study 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.

    Other: Lens A

  • Experimental
    Lens B group

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

    Other: Lens B

Interventions

  • OtherLens A

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

  • OtherLens B

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

06

What researchers measure

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.

    Time frame: Baseline, 6, 12, 18 and 24 months

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6, 12, 18 and 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Apr 2029, 32 months after the start.

Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 32 months is above that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2026
First posted
Apr 23, 2026
StartActual
Aug 26, 2026
Primary completionEst.
Apr 30, 2029
CompletionEst.
Jul 14, 2029
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07547085
Lead sponsor
The Hong Kong Polytechnic University
Collaborators
Eyebright Medical Technology (Beijing) Co., Ltd.
Responsible party
Sponsor
First posted
Apr 23, 2026
Start date
Aug 26, 2026
Primary completion
Apr 30, 2029 (estimated)
Completion
Jul 14, 2029 (estimated)
Last update
Sep 17, 2026

Study contacts

Rachel Ka Man Chun, PhD
Contact
rachel.chun@polyu.edu.hk
852-27664224
Dennis Yan Yin Tse, PhD
Contact
dennis.tse@polyu.edu.hk
852-27666096
Rachel Ka Man Chun, PhD
principal investigator · School of Optometry, The Hong Kong Polytechnic University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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