Clinical Trial of Orthokeratology Lens (MCOK-01)

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Test orthokeratology lens; Device: Control orthokeratology lens

• Registration Number: NCT06037850
• Lead Sponsor: Menicon Co., Ltd.

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.

Study Timeline

• Study Start: 2022-07-29
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Patients with myopia and myopic astigmatism
2. Those who are not willing to wear glasses in daily life
3. 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
4. Those who can visit the institution on scheduled dates
5. Those who can receive guidance and tests as required by the investigator
6. Those who fully understand and follow the instructions of the lenses for this clinical trial

Exclusion Criteria

<At screening>

1. Best corrected 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. 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)
4. 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.)
5. The medical history of refractive corneal surgery
6. Those in need of a strength out of the scope of lens for this clinical trial
7. Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
8. All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
9. Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding
10. Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days
11. Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
12. Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses)
13. Minor/adult subjects who lack mental capacity
14. Other not suitable for this clinical trial at investigator's discretion <At the beginning of the wearing>

(1) Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Test orthokeratology lens	Randomized to Treatment
Control	Control orthokeratology lens	Randomized to Control

Primary Outcome Measures

Name	Time	Method
Axial length	1 year	axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Refraction	1 year	spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
Visual acuity	1 year	uncorrected visual acuity measured using logMAR chart

Secondary Outcome Measures

Name	Time	Method
Adverse Events	1 year	Adverse events are classified into moderate, middle, or severe.

Trial Locations

Locations (3)

I&VISION Research Centre; 🇸🇬 Singapore, Singapore

Myopia Specialist Centre; 🇸🇬 Singapore, Singapore

Stan Isaacs; 🇸🇬 Singapore, Singapore