search
Back to results

Clinical Trial of Orthokeratology Lens (MCOK-01)

Primary Purpose

Myopia

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Test orthokeratology lens
Control orthokeratology lens
Sponsored by
Menicon Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

6 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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 Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses) Minor/adult subjects who lack mental capacity 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

Sites / Locations

  • I&VISION Research Centre
  • Myopia Specialist Centre
  • Stan Isaacs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

Randomized to Treatment

Randomized to Control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
Adverse events are classified into moderate, middle, or severe.

Full Information

First Posted
August 23, 2023
Last Updated
September 7, 2023
Sponsor
Menicon Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT06037850
Brief Title
Clinical Trial of Orthokeratology Lens (MCOK-01)
Official Title
Clinical Trial of Orthokeratology Lens (MCOK-01)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menicon Co., Ltd.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Randomized to Treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Randomized to Control
Intervention Type
Device
Intervention Name(s)
Test orthokeratology lens
Intervention Description
Randomized to test orthokeratology lens worn during sleep every night
Intervention Type
Device
Intervention Name(s)
Control orthokeratology lens
Intervention Description
Randomized to control orthokeratology lens worn during sleep every night
Primary Outcome Measure Information:
Title
Visual acuity
Description
uncorrected visual acuity measured using logMAR chart
Time Frame
1 year
Title
Axial length
Description
axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Time Frame
1 year
Title
Refraction
Description
spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events are classified into moderate, middle, or severe.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses) Minor/adult subjects who lack mental capacity 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Isaacs
Organizational Affiliation
I & Vision Research Centre Pte. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
I&VISION Research Centre
City
Singapore
ZIP/Postal Code
248649
Country
Singapore
Facility Name
Myopia Specialist Centre
City
Singapore
ZIP/Postal Code
248649
Country
Singapore
Facility Name
Stan Isaacs
City
Singapore
ZIP/Postal Code
248649
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Orthokeratology Lens (MCOK-01)

We'll reach out to this number within 24 hrs