MyopiaNCT06037850
Clinical Trial of Orthokeratology Lens (MCOK-01)
A study testing Test orthokeratology lens in people with Myopia, run by Menicon Co., Ltd. at 3 sites in Singapore.
Trial summary
A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens Read more about this study
- Who is it for?
- Ages 6 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Test orthokeratology lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 3 sitesSingapore
- Study dates
- 29 Jul 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with myopia and myopic astigmatism
- Those who are not willing to wear glasses in daily life
- Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness
- Those who can visit the institution on scheduled dates
- Those who can receive guidance and tests as required by the investigator
- Those who fully understand and follow the instructions of the lenses for this clinical trial
Who cannot join
- <At screening>
- Best corrected vision acuity of less than 0.8 with spectacles
- Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D
- Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
- The medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc.)
- The medical history of refractive corneal surgery
Show all 16Show fewer
- Those in need of a strength out of the scope of lens for this clinical trial
- Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
- All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
- Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding
- Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days
- Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
- Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses)
- Minor/adult subjects who lack mental capacity
- Other not suitable for this clinical trial at investigator's discretion <At the beginning of the wearing>
- Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
I&VISION Research Centre
Singapore, 248649
Myopia Specialist Centre
Singapore, 248649
Stan Isaacs
Singapore, 248649
About this study
A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
Read the detailed description
The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.
- Conditions
- Myopia
- Being tested
- Test orthokeratology lens, Control orthokeratology lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test orthokeratology lensDevice
Randomized to test orthokeratology lens worn during sleep every night
Control orthokeratology lensDevice
Randomized to control orthokeratology lens worn during sleep every night
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Randomized to Treatment Receives: Device: Test orthokeratology lens |
| Control | Active comparator | Randomized to Control Receives: Device: Control orthokeratology lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
uncorrected visual acuity measured using logMAR chart
Measured: 1 year
Axial length
axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Measured: 1 year
Refraction
spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
Measured: 1 year
Secondary outcomes (1)
Adverse Events
Adverse events are classified into moderate, middle, or severe.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start29 Jul 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menicon Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stan Isaacs, Study director, I & Vision Research Centre Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037850
- Sponsor's protocol ID
- MCOK-01
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Orthokeratology Lens (MCOK-01)
- ClinicalTrials.gov ID
- NCT06037850
- Acronym / sponsor ID
- MCOK-01
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Menicon Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 14 Sep 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.
A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
Detailed description
The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Test orthokeratology lensRandomized to Treatment |
| Control | Active comparator | Device: Control orthokeratology lensRandomized to Control |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with myopia and myopic astigmatism
- Those who are not willing to wear glasses in daily life
- Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness
- Those who can visit the institution on scheduled dates
- Those who can receive guidance and tests as required by the investigator
Key exclusion criteria (16 listed)
- <At screening>
- Best corrected vision acuity of less than 0.8 with spectacles
- Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D
- Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
- The medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc.)
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 |
|---|---|---|
| Test orthokeratology lensRandomized to test orthokeratology lens worn during sleep every night | Device | Treatment |
| Control orthokeratology lensRandomized to control orthokeratology lens worn during sleep every night | Device | Control |
Primary outcome
Visual acuity
Time frame: 1 year
uncorrected visual acuity measured using logMAR chart
Axial length
Time frame: 1 year
axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Refraction
Time frame: 1 year
spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
1 secondary outcome
Adverse Events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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.
Stan Isaacs study director
I & Vision Research Centre Pte. Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test orthokeratology lens in people with Myopia, run by Menicon Co., Ltd. at 3 sites in Singapore.
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 6 inclusion and 16 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual acuity (time frame: 1 year). The study lists 3 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 7 Feb 2025.