CClinicalTrials.gg
CompletedNCT06037850Updated Feb 7, 2025

Clinical Trial of Orthokeratology Lens (MCOK-01)

An interventional study of Test orthokeratology lens and Control orthokeratology lens in Myopia, sponsored by Menicon Co., Ltd.. Completed at 3 sites in Singapore. Open to participants aged 6 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Menicon Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2022, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
390
Allocation
Randomized
Ages
6 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Myopia

Browse trials for

03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 390 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Menicon Co., Ltd. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
390 participants (actual)

Study arms

  • Experimental
    Treatment

    Randomized to Treatment

    Device: Test orthokeratology lens

  • Active comparator
    Control

    Randomized to Control

    Device: Control orthokeratology lens

Interventions

  • DeviceTest orthokeratology lens

    Randomized to test orthokeratology lens worn during sleep every night

  • DeviceControl orthokeratology lens

    Randomized to control orthokeratology lens worn during sleep every night

06

What researchers measure

Primary outcomes

  1. Visual acuity

    uncorrected visual acuity measured using logMAR chart

    Time frame: 1 year

  2. Axial length

    axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)

    Time frame: 1 year

  3. Refraction

    spherical and cylinder power in diopter for best corrected visual acuity measured subjectively

    Time frame: 1 year

Secondary outcomes

  1. Adverse Events

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

    Time frame: 1 year

07

Study locations

3 sites
  • I&VISION Research Centre
    Singapore, 248649, Singapore
  • Myopia Specialist Centre
    Singapore, 248649, Singapore
  • Stan Isaacs
    Singapore, 248649, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06037850
Lead sponsor
Menicon Co., Ltd.
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Jul 29, 2022
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Feb 7, 2025

Study contacts

Stan Isaacs
study director · I & Vision Research Centre Pte. Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion