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.
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.
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).
Menicon Co., Ltd.
Lead sponsor