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NCT Number: NCT07047924

A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients 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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Myopic Astigmatism Refractive Errors

Age range

6 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eyecare Kids, Hillsdale, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

MCOK-01

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. Improvement of monocular uncorrected distance visual acuity

    Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment

    Assessed with a logMAR chart. Endpoint will be measured by a set of descriptive statistics.

  2. 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

    Assessed using a logMAR chart

  3. Changes in manifest sphere

    Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment

    Measured with a subjective refraction test

  4. 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

    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)

  5. Corneal topography changes

    Time frame: 12 months following enrolment

    Measured with a corneal topographer

  6. Change in absolute corneal astigmatism

    Time frame: 12 months following enrolment

    Measured with a corneal topographer

  7. Number of discontinued participants and the reasons for discontinuation

    Time frame: Any time within the 12-months enrolment window

    Ongoing participation rates will be continuously monitored

  8. 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

    Patient reported at scheduled study visits

  9. Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment

    Time frame: 12 months following enrolment

    Measured with a subjective refraction test

  10. Signs/symptoms and complications from subjective questionnaires

    Time frame: 1 month, 6 months, and 12 months following enrolment

    Assessed by the subjective questionnaires completed by participants

  11. Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline

    Time frame: 6 months and 12 months following enrolment

    Measured using a tonometer

  12. Descriptive statistics of specular microscopy measurements

    Time frame: 12 months following enrolment

    Measured using a specular microscope. Specific parameters include Endothelial Cell Morphology (Cell density (cells/mm2), Polymegethism (CV) and Pleomorphism (percentage of hexagonal cells))

  13. Descriptive statistics of central corneal thickness

    Time frame: 6 months, and 12 months following enrolment

    Measured using a specular microscope.

  14. Frequency and reasons for lens replacement

    Time frame: Any time within the 12-months enrolment window

    Patient reported at scheduled study visits

  15. 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

  16. Stability in manifest refractive error

    Time frame: 1 month and 3 months following enrolment

    Measured with a subjective refraction test. Proportion of eyes with manifest sphere change within ±0.50 D between 1-month and 3-month visit.

  17. Stability in unaided visual acuity

    Time frame: 1 month and 3 months following enrolment

    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.

Sponsors and collaborators

Lead sponsor

Menicon Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism

Acronym: SEMOA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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