MyopiaSEMOANCT07047924
A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism
A study testing MCOK-01 in people with Myopia and Myopic Astigmatism, run by Menicon Co., Ltd. at 4 sites in Australia.
Trial summary
This is a prospective, multi-centre, single-arm clinical trial to evaluate the effectiveness and safety of MCOK-01 lenses in patients with myopia and myopic astigmatism who need dioptric correction. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Myopia, Myopic Astigmatism
- What is being tested?
- MCOK-01
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesAustralia
- Study dates
- 1 Jul 2025to 1 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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant diagnosed with myopia and myopic astigmatism, documented by an eye care practitioner.
- Participant is between 6-40 years old inclusive.
- Participant is not motivated to wear glasses in daily life.
- Participants are of Caucasian ethnicity (must be >50% of study population) or other non-east Asian ethnic groups (Indian, Sri-Lankan, Pakistani, etc). Neither parent of participant can be east-asian.
- Provision of written informed consent.
- Participants understand and agree to all requirements of the clinical trial; visit schedule, investigator guidance, follow-lens instructions, etc
Who cannot join
- Best corrected distance 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.
- Participants of East-Asian ethnicity (Chinese, Japanese, Korean, etc).
- Participants requiring treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses).
- 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)..
- Medical history of refractive corneal surgery.
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- Slit lamp findings that are more serious than grade 1
- Participants requiring lens parameters outside of the scope of lens for this clinical trial.
- Known eye allergies or conditions that are contraindicated, including sensitivity to any lens care maintenance or packaging solution additives being used in this study
- Corneal abnormalities including keratoconus, corneal dystrophy and/or previous history of ocular herpes infections.
- Currently using Atropine, or have used Atropine eye drops 14 days prior to enrolment.
- For female participants, pregnancy, planned pregnancy during the trial or breastfeeding (pregnancy status provided by verbal confirmation).
- Participation in other clinical trials or participation within the past 30 days.
- Use of orthokeratology lenses within the prior 90 days, extended wear, rigid gas permeable corneal and scleral lenses within the prior 30 days, daily disposable and daily wear within the prior 15 days.
- Mental incapacity.
- Other Participants deemed not suitable for the trial at the investigator's discretion
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites
The University of Melbourne Department of Optometry and Vision Sciences
Carlton, Victoria, 3053
Katerina Kiburg, PhD, 9035 5511 ext. +61 03, katerina.kiburg@unimelb.edu.au
Carol Lakkis, PhD
Eyecare Kids
Hillsdale, New South Wales, 2036
Soojin Nam, M.Optom, 9311 4600 ext. +61 02, soojin@eyecarekids.com.au
Soojin Nam, M.Optom
Queensland University of Technology Optometry and Vision Science
Kelvin Grove, Queensland, 4059
Catherine Foster, 313 85731 ext. +61 07, c.foster@qut.edu.au
Michael Collins, PhD
UNSW School of Optometry and Vision Science
Sydney, New South Wales, 2052
Jackie Tan-Showyin, PhD, BOptom (Hons), 9385 6551 ext. +61 (02), jacqueline.tan@unsw.edu.au
Fiona Stapleton, PhD
About this study
Official title: A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism
This is a prospective, multi-centre, single-arm clinical trial to evaluate the effectiveness and safety of MCOK-01 lenses in patients with myopia and myopic astigmatism who need dioptric correction.
A maximum number of 220 participants are planned to be enrolled , with a minimum of 150 planned to complete the trial (30% dropout). All participants will be enrolled in Australia.
Enrolled participants will wear the lenses every night for up to 12 months, removing them upon waking. 8 follow up visits will be completed during treatment, after: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of wearing the lenses.
- Conditions
- Myopia, Myopic Astigmatism
- Being tested
- MCOK-01
- Keywords
- Myopia, Myopic Astigmatism, Orthokeratology Lenses, Orthokeratology
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCOK-01Device
The investigational device is a Rigid Gas Permeable contact lenses for orthokeratology. MCOK-01 applied the reverse geometry design and adopted the lens material which possesses the highest oxygen permeability among all the materials for orthokeratology lens.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | All participants will be enrolled in the Investigational arm, and treated with the investigational product. Receives: Device: MCOK-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lines of improvement of monocular uncorrected distance visual acuity
Reading of a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
Measured: 12-months following enrolment
Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR
Measured using a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
A level of attempted versus achieved reduction in manifest refractive error
Using a Phoropter/Refractor. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
Measured: 12 months following enrolment
Number and rates (by type of event and relation to device) of serious and significant adverse events
Adverse events will be self-reported by participants to investigative team
Measured: Any time within the 12-months enrolment window
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
Adverse events will be self-reported by participants to investigative team
Measured: Any time within the 12-months enrolment window
Number of slit lamp results above grade 2
Assessed using a slit lamp
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Number and rate of cases of loss of; monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar).
Assessed with a logMAR chart
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Secondary outcomes (17)
Improvement of monocular uncorrected distance visual acuity
Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics.
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Change in best corrected spectacle visual acuity
Assessed using a logMAR chart
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Changes in manifest sphere
Measured with a subjective refraction test
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
A level of attempted versus achieved reduction in manifest refractive error
Measured with a subjective refraction test. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Corneal topography changes
Measured with a corneal topographer
Measured: 12 months following enrolment
Change in absolute corneal astigmatism
Measured with a corneal topographer
Measured: 12 months following enrolment
Number of discontinued participants and the reasons for discontinuation
Ongoing participation rates will be continuously monitored
Measured: Any time within the 12-months enrolment window
Number and rates of average wear time per day
Patient reported at scheduled study visits
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment
Measured with a subjective refraction test
Measured: 12 months following enrolment
Signs/symptoms and complications from subjective questionnaires
Assessed by the subjective questionnaires completed by participants
Measured: 1 month, 6 months, and 12 months following enrolment
Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline
Measured using a tonometer
Measured: 6 months and 12 months following enrolment
Descriptive statistics of specular microscopy measurements
Measured using a specular microscope. Specific parameters include Endothelial Cell Morphology (Cell density (cells/mm2), Polymegethism (CV) and Pleomorphism (percentage of hexagonal cells))
Measured: 12 months following enrolment
Descriptive statistics of central corneal thickness
Measured using a specular microscope.
Measured: 6 months, and 12 months following enrolment
Frequency and reasons for lens replacement
Patient reported at scheduled study visits
Measured: Any time within the 12-months enrolment window
Damage or scratches on the lenses
Measured: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Stability in manifest refractive error
Measured with a subjective refraction test. Proportion of eyes with manifest sphere change within ±0.50 D between 1-month and 3-month visit.
Measured: 1 month and 3 months following enrolment
Stability in unaided visual acuity
Measured using a logMAR chart. Proportion of eyes with unaided visual acuity change within 1 line (0.1 logMAR) between 1-month and 3-month visit.
Measured: 1 month and 3 months following enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menicon Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047924
- Sponsor's protocol ID
- MCOK-3-AUS
- Acronym
- SEMOA
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism
- ClinicalTrials.gov ID
- NCT07047924
- Acronym / sponsor ID
- SEMOA / MCOK-3-AUS
- Conditions
- Myopia, Myopic Astigmatism
- Keywords
- Myopia, Myopic Astigmatism, Orthokeratology Lenses, Orthokeratology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Menicon Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Jul 2025 (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 is a prospective, multi-centre, single-arm clinical trial to evaluate the effectiveness and safety of MCOK-01 lenses in patients with myopia and myopic astigmatism who need dioptric correction.
A maximum number of 220 participants are planned to be enrolled , with a minimum of 150 planned to complete the trial (30% dropout). All participants will be enrolled in Australia.
Enrolled participants will wear the lenses every night for up to 12 months, removing them upon waking. 8 follow up visits will be completed during treatment, after: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of wearing the lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: MCOK-01All participants will be enrolled in the Investigational arm, and treated with the investigational product. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Participant diagnosed with myopia and myopic astigmatism, documented by an eye care practitioner.
- Participant is between 6-40 years old inclusive.
- Participant is not motivated to wear glasses in daily life.
- Participants are of Caucasian ethnicity (must be >50% of study population) or other non-east Asian ethnic groups (Indian, Sri-Lankan, Pakistani, etc). Neither parent of participant can be east-asian.
- Provision of written informed consent.
Key exclusion criteria (16 listed)
- Best corrected distance 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.
- Participants of East-Asian ethnicity (Chinese, Japanese, Korean, etc).
- Participants requiring treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses).
- 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 |
|---|---|---|
| MCOK-01The investigational device is a Rigid Gas Permeable contact lenses for orthokeratology. MCOK-01 applied the reverse geometry design and adopted the lens material which possesses the highest oxygen permeability among all the materials for orthokeratology lens. | Device | Investigational |
Primary outcome
Lines of improvement of monocular uncorrected distance visual acuity
Time frame: 12-months following enrolment
Reading of a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Measured using a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
A level of attempted versus achieved reduction in manifest refractive error
Time frame: 12 months following enrolment
Using a Phoropter/Refractor. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
Number and rates (by type of event and relation to device) of serious and significant adverse events
Time frame: Any time within the 12-months enrolment window
Adverse events will be self-reported by participants to investigative team
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
Time frame: Any time within the 12-months enrolment window
Adverse events will be self-reported by participants to investigative team
Number of slit lamp results above grade 2
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Assessed using a slit lamp
Number and rate of cases of loss of; monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar).
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Assessed with a logMAR chart
17 secondary outcomes
Improvement of monocular uncorrected distance visual acuity
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Change in best corrected spectacle visual acuity
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Changes in manifest sphere
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
A level of attempted versus achieved reduction in manifest refractive error
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Corneal topography changes
Time frame: 12 months following enrolment
Change in absolute corneal astigmatism
Time frame: 12 months following enrolment
Number of discontinued participants and the reasons for discontinuation
Time frame: Any time within the 12-months enrolment window
Number and rates of average wear time per day
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment
Time frame: 12 months following enrolment
Signs/symptoms and complications from subjective questionnaires
Time frame: 1 month, 6 months, and 12 months following enrolment
Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline
Time frame: 6 months and 12 months following enrolment
Descriptive statistics of specular microscopy measurements
Time frame: 12 months following enrolment
Descriptive statistics of central corneal thickness
Time frame: 6 months, and 12 months following enrolment
Frequency and reasons for lens replacement
Time frame: Any time within the 12-months enrolment window
Damage or scratches on the lenses
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Stability in manifest refractive error
Time frame: 1 month and 3 months following enrolment
Stability in unaided visual acuity
Time frame: 1 month and 3 months following enrolment
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 2 Jul 2025.
- 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.
UNSW School of Optometry and Vision Science
Sydney, Australia
Queensland University of Technology Optometry and Vision Science
Kelvin Grove, Australia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCOK-01 in people with Myopia and Myopic Astigmatism, run by Menicon Co., Ltd. at 4 sites in Australia.
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: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lines of improvement of monocular uncorrected distance visual acuity (time frame: 12-months following enrolment). The study lists 7 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 2 Jul 2025.