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

NCT ID: NCT07047924

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational

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

Group Type: EXPERIMENTAL

MCOK-01

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menicon Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eyecare Kids

Hillsdale, New South Wales, Australia

UNSW School of Optometry and Vision Science

Sydney, New South Wales, Australia

Queensland University of Technology Optometry and Vision Science

Kelvin Grove, Queensland, Australia

The University of Melbourne Department of Optometry and Vision Sciences

Carlton, Victoria, Australia

Countries

Australia

Facility Contacts

Soojin Nam, M.Optom

Role: primary

soojin@eyecarekids.com.au

9311 4600 ext. +61 02

Jackie Tan-Showyin, PhD, BOptom (Hons)

Role: primary

jacqueline.tan@unsw.edu.au

9385 6551 ext. +61 (02)

Catherine Foster

Role: primary

c.foster@qut.edu.au

313 85731 ext. +61 07

Katerina Kiburg, PhD

Role: primary

katerina.kiburg@unimelb.edu.au

9035 5511 ext. +61 03

Other Identifiers

MCOK-3-AUS

Identifier Type: -

Identifier Source: org_study_id