A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism

NCT07047924 | Not Yet Recruiting

• 1 other identifier: MCOK-3-AUS
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

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.

Conditions

Myopia; Myopic Astigmatism

Keywords

Myopia; Myopic Astigmatism; Orthokeratology Lenses; Orthokeratology

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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)

  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

  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

  Any time within the 12-months enrolment window

• Number of slit lamp results above grade 2

  Assessed using a slit lamp

  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

  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

  1 month, 3 months, 6 months, 9 months, and 12 months following enrolment

• Change in best corrected spectacle visual acuity

  1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment

• Changes in manifest sphere

  1 month, 3 months, 6 months, 9 months, and 12 months following enrolment

• A level of attempted versus achieved reduction in manifest refractive error

  1 month, 3 months, 6 months, 9 months, and 12 months following enrolment

• Corneal topography changes

  12 months following enrolment

Study Arms (1)

Investigational

EXPERIMENTAL

All participants will be enrolled in the Investigational arm, and treated with the investigational product.

Device: MCOK-01

Interventions

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.

Investigational

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menicon Co., Ltd.: lead

Study Sites (4)

Eyecare Kids

Hillsdale, New South Wales, 2036, Australia

Location

UNSW School of Optometry and Vision Science

Sydney, New South Wales, 2052, Australia

Location

Queensland University of Technology Optometry and Vision Science

Kelvin Grove, Queensland, 4059, Australia

Location

The University of Melbourne Department of Optometry and Vision Sciences

Carlton, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)