Clinical Trial of Orthokeratology Lens (MCOK-01)

Menicon Co., Ltd.3 sites in 1 country390 target enrollmentJuly 29, 2022

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Menicon Co., Ltd.
Enrollment: 390
Locations: 3
Primary Endpoint: Axial length
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens

Detailed Description

The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.

Registry

clinicaltrials.gov

Start Date

July 29, 2022

End Date

October 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Menicon Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with myopia and myopic astigmatism
•Those who are not willing to wear glasses in daily life
•Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness
•Those who can visit the institution on scheduled dates
•Those who can receive guidance and tests as required by the investigator
•Those who fully understand and follow the instructions of the lenses for this clinical trial

Exclusion Criteria

•\<At screening\>
•Best corrected 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
•Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
•The 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.)
•The medical history of refractive corneal surgery
•Those in need of a strength out of the scope of lens for this clinical trial
•Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
•All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
•Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding