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

Launched by MENICON CO., LTD. · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special type of contact lens called orthokeratology lenses (MCOK-01) to see if they are safe and effective for people with myopia (nearsightedness) and myopic astigmatism (a condition that causes blurry vision due to an irregularly shaped eye). The lenses are worn overnight and removed in the morning, helping to correct vision during the day without the need for glasses or regular contact lenses.

People who may be eligible to join are between 6 and 40 years old, have been diagnosed with myopia and myopic astigmatism, and prefer not to wear glasses every day. The study will include mostly participants of Caucasian or certain South Asian backgrounds, but not those of East Asian descent. If you join, you’ll wear the lenses every night for up to a year and visit the doctor eight times to check your progress and eye health. The trial aims to include up to 220 people in Australia, and it will carefully monitor how well the lenses work and if there are any side effects.

Gender

ALL

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