An interventional study of MCOK-01 in Myopia and Myopic Astigmatism, sponsored by Menicon Co., Ltd.. Not yet recruiting at 4 sites in Australia. Open to participants aged 6 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Menicon Co., Ltd. · Not applicable, Interventional, and Treatment
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 220 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Menicon Co., Ltd. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will be enrolled in the Investigational arm, and treated with the investigational product.
Device: MCOK-01
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.
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.
Time frame: 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.
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
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)
Time frame: 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
Time frame: 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
Time frame: Any time within the 12-months enrolment window
Number of slit lamp results above grade 2
Assessed using a slit lamp
Time frame: 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
Time frame: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Improvement of monocular uncorrected distance visual acuity
Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics.
Time frame: 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
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
Measured with a subjective refraction test
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
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)
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Corneal topography changes
Measured with a corneal topographer
Time frame: 12 months following enrolment
Change in absolute corneal astigmatism
Measured with a corneal topographer
Time frame: 12 months following enrolment
Number of discontinued participants and the reasons for discontinuation
Ongoing participation rates will be continuously monitored
Time frame: Any time within the 12-months enrolment window
Number and rates of average wear time per day
Patient reported at scheduled study visits
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
Measured with a subjective refraction test
Time frame: 12 months following enrolment
Signs/symptoms and complications from subjective questionnaires
Assessed by the subjective questionnaires completed by participants
Time frame: 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
Time frame: 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))
Time frame: 12 months following enrolment
Descriptive statistics of central corneal thickness
Measured using a specular microscope.
Time frame: 6 months, and 12 months following enrolment
Frequency and reasons for lens replacement
Patient reported at scheduled study visits
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
Measured with a subjective refraction test. Proportion of eyes with manifest sphere change within ±0.50 D between 1-month and 3-month visit.
Time frame: 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.
Time frame: 1 month and 3 months following enrolment
Plan to share: No
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Menicon Co., Ltd.