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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07047924
Registration number
NCT07047924
Ethics application status
Date submitted
24/06/2025
Date registered
2/07/2025
Date last updated
2/07/2025
Titles & IDs
Public title
A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism
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Scientific title
A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism
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Secondary ID [1]
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MCOK-3-AUS
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Universal Trial Number (UTN)
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Trial acronym
SEMOA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myopia
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Myopic Astigmatism
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MCOK-01
Experimental: Investigational - All participants will be enrolled in the Investigational arm, and treated with the investigational product.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Lines of improvement of monocular uncorrected distance visual acuity
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Assessment method [1]
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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.
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Timepoint [1]
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12-months following enrolment
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Primary outcome [2]
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Proportion of eyes achieved uncorrected distance visual acuity of =0.30 logMAR, =0.20 logMAR, =0.10 logMAR, and =0.00 logMAR
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Assessment method [2]
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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.
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Timepoint [2]
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1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Primary outcome [3]
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A level of attempted versus achieved reduction in manifest refractive error
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Assessment method [3]
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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)
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Timepoint [3]
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12 months following enrolment
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Primary outcome [4]
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Number and rates (by type of event and relation to device) of serious and significant adverse events
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Assessment method [4]
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Adverse events will be self-reported by participants to investigative team
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Timepoint [4]
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Any time within the 12-months enrolment window
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Primary outcome [5]
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Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
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Assessment method [5]
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Adverse events will be self-reported by participants to investigative team
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Timepoint [5]
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Any time within the 12-months enrolment window
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Primary outcome [6]
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Number of slit lamp results above grade 2
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Assessment method [6]
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Assessed using a slit lamp
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Timepoint [6]
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Primary outcome [7]
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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).
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Assessment method [7]
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Assessed with a logMAR chart
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Timepoint [7]
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [1]
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Improvement of monocular uncorrected distance visual acuity
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Assessment method [1]
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Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics.
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Timepoint [1]
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1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [2]
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Change in best corrected spectacle visual acuity
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Assessment method [2]
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Assessed using a logMAR chart
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Timepoint [2]
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [3]
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Changes in manifest sphere
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Assessment method [3]
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Measured with a subjective refraction test
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Timepoint [3]
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1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [4]
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A level of attempted versus achieved reduction in manifest refractive error
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Assessment method [4]
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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)
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Timepoint [4]
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1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [5]
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Corneal topography changes
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Assessment method [5]
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Measured with a corneal topographer
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Timepoint [5]
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12 months following enrolment
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Secondary outcome [6]
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Change in absolute corneal astigmatism
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Assessment method [6]
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Measured with a corneal topographer
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Timepoint [6]
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12 months following enrolment
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Secondary outcome [7]
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Number of discontinued participants and the reasons for discontinuation
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Assessment method [7]
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Ongoing participation rates will be continuously monitored
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Timepoint [7]
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Any time within the 12-months enrolment window
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Secondary outcome [8]
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Number and rates of average wear time per day
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Assessment method [8]
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Patient reported at scheduled study visits
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Timepoint [8]
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [9]
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Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment
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Assessment method [9]
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Measured with a subjective refraction test
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Timepoint [9]
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12 months following enrolment
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Secondary outcome [10]
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Signs/symptoms and complications from subjective questionnaires
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Assessment method [10]
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Assessed by the subjective questionnaires completed by participants
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Timepoint [10]
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1 month, 6 months, and 12 months following enrolment
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Secondary outcome [11]
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Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline
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Assessment method [11]
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Measured using a tonometer
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Timepoint [11]
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6 months and 12 months following enrolment
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Secondary outcome [12]
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Descriptive statistics of specular microscopy measurements
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Assessment method [12]
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Measured using a specular microscope. Specific parameters include Endothelial Cell Morphology (Cell density (cells/mm2), Polymegethism (CV) and Pleomorphism (percentage of hexagonal cells))
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Timepoint [12]
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12 months following enrolment
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Secondary outcome [13]
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Descriptive statistics of central corneal thickness
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Assessment method [13]
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Measured using a specular microscope.
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Timepoint [13]
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6 months, and 12 months following enrolment
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Secondary outcome [14]
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Frequency and reasons for lens replacement
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Assessment method [14]
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Patient reported at scheduled study visits
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Timepoint [14]
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Any time within the 12-months enrolment window
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Secondary outcome [15]
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Damage or scratches on the lenses
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Assessment method [15]
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Timepoint [15]
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1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
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Secondary outcome [16]
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Stability in manifest refractive error
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Assessment method [16]
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Measured with a subjective refraction test. Proportion of eyes with manifest sphere change within ±0.50 D between 1-month and 3-month visit.
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Timepoint [16]
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1 month and 3 months following enrolment
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Secondary outcome [17]
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Stability in unaided visual acuity
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Assessment method [17]
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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.
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Timepoint [17]
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1 month and 3 months following enrolment
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Eligibility
Key inclusion criteria
1. Participant diagnosed with myopia and myopic astigmatism, documented by an eye care practitioner.
2. Participant is between 6-40 years old inclusive.
3. Participant is not motivated to wear glasses in daily life.
4. 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.
5. Provision of written informed consent.
6. Participants understand and agree to all requirements of the clinical trial; visit schedule, investigator guidance, follow-lens instructions, etc
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Minimum age
6
Years
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Maximum age
40
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Best corrected distance vision acuity of less than 0.8 with spectacles.
2. Subjective refraction test shows spherical power greater than -6.00D,less than -0.50D or astigmatism greater than 1.5D.
3. Participants of East-Asian ethnicity (Chinese, Japanese, Korean, etc).
4. 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).
5. 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)..
6. Medical history of refractive corneal surgery.
7. Slit lamp findings that are more serious than grade 1
8. Participants requiring lens parameters outside of the scope of lens for this clinical trial.
9. Known eye allergies or conditions that are contraindicated, including sensitivity to any lens care maintenance or packaging solution additives being used in this study
10. Corneal abnormalities including keratoconus, corneal dystrophy and/or previous history of ocular herpes infections.
11. Currently using Atropine, or have used Atropine eye drops 14 days prior to enrolment.
12. For female participants, pregnancy, planned pregnancy during the trial or breastfeeding (pregnancy status provided by verbal confirmation).
13. Participation in other clinical trials or participation within the past 30 days.
14. 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.
15. Mental incapacity.
16. Other Participants deemed not suitable for the trial at the investigator's discretion
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Eyecare Kids - Hillsdale
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Recruitment hospital [2]
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UNSW School of Optometry and Vision Science - Sydney
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Recruitment hospital [3]
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Queensland University of Technology Optometry and Vision Science - Kelvin Grove
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Recruitment hospital [4]
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The University of Melbourne Department of Optometry and Vision Sciences - Carlton
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Recruitment postcode(s) [1]
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2036 - Hillsdale
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Recruitment postcode(s) [2]
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2052 - Sydney
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Recruitment postcode(s) [3]
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4059 - Kelvin Grove
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Recruitment postcode(s) [4]
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3053 - Carlton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Menicon Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT07047924
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07047924
Download to PDF