Clinical Trial of Orthokeratology Lens (MCOK-01)

Myopia Clinical Trial

Official title:

Clinical Trial of Orthokeratology Lens (MCOK-01)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06037850
• Other study ID #: MCOK-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Menicon Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test orthokeratology lens
Randomized to test orthokeratology lens worn during sleep every night
• Control orthokeratology lens
Randomized to control orthokeratology lens worn during sleep every night

Locations

Country	Name	City	State
Singapore	I&VISION Research Centre	Singapore
Singapore	Myopia Specialist Centre	Singapore
Singapore	Stan Isaacs	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Menicon Co., Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	uncorrected visual acuity measured using logMAR chart	1 year
Primary	Axial length	axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)	1 year
Primary	Refraction	spherical and cylinder power in diopter for best corrected visual acuity measured subjectively	1 year
Secondary	Adverse Events	Adverse events are classified into moderate, middle, or severe.	1 year