Clinical Trial of Orthokeratology Lens (MCOK-01)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Test orthokeratology lens; Device: Control 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 Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 248649
    • I&VISION Research Centre
  • Singapore, Singapore, 248649
    • Myopia Specialist Centre
  • Singapore, Singapore, 248649
    • Stan Isaacs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Randomized to Treatment	Device: Test orthokeratology lens; Randomized to test orthokeratology lens worn during sleep every night
Active Comparator: Control; Randomized to Control	Device: Control orthokeratology lens; Randomized to control orthokeratology lens worn during sleep every night

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events are classified into moderate, middle, or severe.	1 year

Collaborators and Investigators

• Sponsor: Menicon Co., Ltd.
• Investigators: Study Director: Stan Isaacs, I & Vision Research Centre Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: MCOK-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No