MyopiaNCT05886348
The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
A study testing Model-A Novel spectacle lens, Model-B Novel spectacle lens and Single vision spectacle lens in people with Myopia, run by HOYA Lens Thailand LTD. at 5 sites in China.
Trial summary
The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Model-A Novel spectacle lens, Model-B Novel spectacle lens and Single vision spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 5 sitesChina
- Study dates
- 31 Jul 2023to 31 May 2027
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant and parent (or guardian) are able and willing to provide consent
- Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements
- Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to
- Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study
- Age at time of parent or guardian consent and participant assent: 7 - 13 years old
- Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye.
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- Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye
- Cycloplegic autorefraction anisometropia of 1.50 D or less
- Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.10 in each eye.
Who cannot join
- Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops
- Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development
- (a) Have received treatment of myopic control pharmaceutical medication (e.g., atropine) or light fundus illuminance therapy (e.g., repeated red light therapy) within 6 months prior to entry into this study. (b) Have received treatment of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal or less than 0.50 D SER) etc. within one month prior to entry into this study.
- Participant with clinically significant strabismus (including intermittent tropia)
- Medical history of binocular vision abnormalities
- Participant with amblyopia
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- Participation in a clinical trial within 30 days prior to entry into this study or during participation
- Previous intraocular surgery
- Participant who, in the judgment of the Investigator, presence of any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
- Any medical treatment or medication which might have an influence on vision or interfere with study assessments
- Pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Tongren Hospital, Capital Medical University
Beijing
Guangzhou Aier Eye Hospital
Guangzhou
Eye and ENT Hospital of Fudan University
Shanghai
Shengyang He Eye Specialist Hospital
Shengyang
Tianjin Medical University Eye Hospital
Tianjin
About this study
The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
Read the detailed description
This is a 3-year prospective, multicenter, randomized, and single-masked*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses.
The treatment arms are:
- Model A Novel spectacle lens
- Model B Novel spectacle lens
- Single vision spectacle lens
Single-masked:
The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.
- Conditions
- Myopia
- Being tested
- Model-A Novel spectacle lens, Model-B Novel spectacle lens, Single vision spectacle lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model-A Novel spectacle lensDevice
Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months
Model-B Novel spectacle lensDevice
Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months
Single vision spectacle lensDevice
Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months
| Study group | Role | What they receive |
|---|---|---|
| Model-A Novel Spectacle lens | Experimental | Not described Receives: Device: Model-A Novel spectacle lens |
| Model-B Novel Spectacle lens | Experimental | Not described Receives: Device: Model-B Novel spectacle lens |
| Single Vision Spectacle lens | Other | Not described Receives: Device: Single vision spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants.
Measured: 24 months
Spherical equivalent cycloplegic autorefraction
The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants
Measured: 24 months
Secondary outcomes (2)
Axial length
Measured: 36 months
Spherical equivalent cycloplegic autorefraction
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start31 Jul 2023
- Primary completion25 Jul 2026
- Study completion31 May 2027 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- HOYA Lens Thailand LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886348
- Sponsor's protocol ID
- DG2-3A
- Status last verified
- Mar 2026
- First submitted
- 23 May 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
- ClinicalTrials.gov ID
- NCT05886348
- Acronym / sponsor ID
- DG2-3A
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 249 participants (actual)
- Lead sponsor
- HOYA Lens Thailand LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Jun 2023 (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 clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
Detailed description
This is a 3-year prospective, multicenter, randomized, and single-masked*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses.
The treatment arms are:
- Model A Novel spectacle lens
- Model B Novel spectacle lens
- Single vision spectacle lens
Single-masked:
The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Model-A Novel Spectacle lens | Experimental | Device: Model-A Novel spectacle lens |
| Model-B Novel Spectacle lens | Experimental | Device: Model-B Novel spectacle lens |
| Single Vision Spectacle lens | Other | Device: Single vision spectacle lens |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Participant and parent (or guardian) are able and willing to provide consent
- Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements
- Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to
- Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study
- Age at time of parent or guardian consent and participant assent: 7 - 13 years old
Key exclusion criteria (11 listed)
- Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops
- Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development
- (a) Have received treatment of myopic control pharmaceutical medication (e.g., atropine) or light fundus illuminance therapy (e.g., repeated red light therapy) within 6 months prior to entry into this study. (b) Have received treatment of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal or less than 0.50 D SER) etc. within one month prior to entry into this study.
- Participant with clinically significant strabismus (including intermittent tropia)
- Medical history of binocular vision abnormalities
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 |
|---|---|---|
| Model-A Novel spectacle lensModel-A Novel spectacle lenses will be given to 1 arm to wear for 36 months | Device | Model-A Novel Spectacle lens |
| Model-B Novel spectacle lensModel-B Novel spectacle lenses will be given to 1 arm to wear for 36 months | Device | Model-B Novel Spectacle lens |
| Single vision spectacle lensSingle Vision Spectacle lenses will be given to 1 arm to wear for 36 months | Device | Single Vision Spectacle lens |
Primary outcome
Axial length
Time frame: 24 months
The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants.
Spherical equivalent cycloplegic autorefraction
Time frame: 24 months
The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants
2 secondary outcomes
Axial length
Time frame: 36 months
Spherical equivalent cycloplegic autorefraction
Time frame: 36 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 18 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model-A Novel spectacle lens, Model-B Novel spectacle lens and Single vision spectacle lens in people with Myopia, run by HOYA Lens Thailand LTD. at 5 sites in China.
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 9 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 18 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 5 sites in China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 24 months). The study lists 2 primary outcomes in all. 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 18 Sep 2026.