MyopiaNCT07686289
A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass
A study testing KG1, KG2 and KG3 in people with Myopia, run by Kubota Vision Inc..
Trial summary
This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control. Read more about this study
- Who is it for?
- Ages 8 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- KG1, KG2 and KG3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2026to 31 Dec 2026
- 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 8 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
- Sign written Informed Consent (and the California Bill of Rights, if applicable).
- Be between age 8-24 (inclusive) and able to understand and assent to participation.
- Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.
- Have a refractive astigmatism of less than or equal to -1.00 D in each eye.
- Have axial length between 23.00 and 25.99 millimeters (mm) in each eye.
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better in each eye.
- Be willing and able to follow instructions and attend the schedule of follow-up visits.
Who cannot join
- Unable or unwilling to provide informed consent and assent.
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Pregnant or lactating or expect to become pregnant during the trial (by self-report).
- Evidence of systemic or ocular abnormality, infection or disease.
- Use of medications that may affect the eye (including, but not limited to, corticosteroids and antimetabolites).
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- Anisometropia ≥ 2.00.
- Subjects who have undergone corneal refractive surgery.
- Use atropine or other anticholinergic drug within the past month.
- Employees or immediate family members of employees of study sites or sponsor.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.
- Conditions
- Myopia
- Being tested
- KG1, KG2, KG3, KG4, KG5
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KG1Device
Unique Kubota Glass optical defocus parameter
KG2Device
Unique Kubota Glass optical defocus parameter
KG3Device
Unique Kubota Glass optical defocus parameter
KG4Device
Unique Kubota Glass optical defocus parameter
KG5Device
Unique Kubota Glass optical defocus parameter
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 2 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 3 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 4 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 5 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 6 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 7 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 8 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 9 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
| Sequence 10 | Experimental | Not described Receives: Device: KG1; Device: KG2; Device: KG3; Device: KG4; Device: KG5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start6 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686289
- Sponsor's protocol ID
- KV-JAX-RCT-002
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass
- ClinicalTrials.gov ID
- NCT07686289
- Acronym / sponsor ID
- KV-JAX-RCT-002
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jul 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.
This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 2 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 3 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 4 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 5 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 6 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 7 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 8 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 9 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
| Sequence 10 | Experimental | Device: KG1, Device: KG2, Device: KG3, Device: KG4, Device: KG5 |
Who may qualify
- Ages
- 8 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
- Sign written Informed Consent (and the California Bill of Rights, if applicable).
- Be between age 8-24 (inclusive) and able to understand and assent to participation.
- Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.
- Have a refractive astigmatism of less than or equal to -1.00 D in each eye.
Key exclusion criteria (10 listed)
- Unable or unwilling to provide informed consent and assent.
- Eye injury or surgery within twelve weeks immediately prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Pregnant or lactating or expect to become pregnant during the trial (by self-report).
- Evidence of systemic or ocular abnormality, infection or disease.
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 |
|---|---|---|
| KG1Unique Kubota Glass optical defocus parameter | Device | Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
| KG2Unique Kubota Glass optical defocus parameter | Device | Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
| KG3Unique Kubota Glass optical defocus parameter | Device | Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
| KG4Unique Kubota Glass optical defocus parameter | Device | Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
| KG5Unique Kubota Glass optical defocus parameter | Device | Sequence 1, Sequence 10, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
Primary outcome
Axial length
Time frame: 1 hour
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing KG1, KG2 and KG3 in people with Myopia, run by Kubota Vision Inc..
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kubota Vision (425-527-3260, boconnor@kubotavision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 1 hour). 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 7 Jul 2026.