MyopiaNCT07547085
Myopia Control Using Novel Soft Contact Lenses
A study testing Lens A and Lens B in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- Lens A and Lens B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Aug 2026to 14 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Optometry Research Clinic, School of Optometry, The Hong Kong Polytechnic University
Kowloon, Hong Kong
Rachel Ka-man Chun, PhD, 852-27664224, rachel.chun@polyu.edu.hk
Dennis Yan-yin Tse, PhD, 852-27666096, dennis.tse@polyu.edu.hk
About this study
Official title: 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.
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.
- Conditions
- Myopia
- Being tested
- Lens A, Lens B
- Keywords
- Myopia control, soft contact lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens AOther
Lens A contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.
Lens BOther
Lens B contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lens A |
| Lens B group | Experimental | Participants in Lens B group will receive Lens B contact lenses for 24 months. Receives: Other: Lens B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start26 Aug 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion14 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Eyebright Medical Technology (Beijing) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Rachel Ka Man Chun, PhD, Principal investigator, School of Optometry, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547085
- Sponsor's protocol ID
- P0059974
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Myopia Control in Children: A Randomized Controlled Trial of Two Novel Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT07547085
- Acronym / sponsor ID
- P0059974
- Conditions
- Myopia
- Keywords
- Myopia control, soft contact lenses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Eyebright Medical Technology (Beijing) Co., Ltd.
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 14 Jul 2029 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Lens AParticipants in Lens A group will receive Lens A contact lenses for 24 months. |
| Lens B group | Experimental | Other: Lens BParticipants in Lens B group will receive Lens B contact lenses for 24 months. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- • Age at enrolment: 7 - 12 (both inclusive) years old Hong Kong Chinese schoolchildren
Key exclusion criteria (9 listed)
- Contraindications for soft contact lenses
- Dry eye with drug intervention within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lens ALens A contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus. | Other | Lens A group |
| Lens BLens B contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus. | Other | Lens B group |
Primary outcome
Cycloplegic refraction change in spherical equivalent refraction (SER)
Time frame: Baseline, 6, 12, 18 and 24 months
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.
1 secondary outcome
Axial length changes
Time frame: Baseline, 6, 12, 18 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Ka Man Chun, PhD principal investigator
School of Optometry, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens A and Lens B in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Ka Man Chun, PhD (852-27664224, rachel.chun@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic refraction change in spherical equivalent refraction (SER) (time frame: Baseline, 6, 12, 18 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.