A clinical trial of Orthokeratology lenses (development code: L001) for myopia and myopic astigmatism of spherical diopter power more than -4.00D up to -6.00D

Ikai Kenzo0 sites90 target enrollmentNovember 5, 2023

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Ikai Kenzo
Enrollment: 90
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 5, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Ikai Kenzo

Eligibility Criteria

Inclusion Criteria

•(1\) Age at the time of consent acquisition: 8 years or older
•(2\) Persons who understand the outline of the clinical trial and signed the consent form. In the case of minors, consent of both the subject and his/her guardian is required.
•(3\) Spherical diopter power of the subject eye is within the applicable range (\-4\.00D to \-6\.00D). However, \-4\.00D is not included. The applicable range of cylindrical degree is 0 to \-1\.50D (for against\-the\-rule astigmatism (70 to 110\), the applicable range of cylindrical power is 0 to \-0\.75D). )
•(4\) Best\-corrected visual acuity of the subject eye: 1\.0 or better
•(5\) The corneal refractive power (weak principal meridian value) of the subject eye: 40\.00D to 46\.25D
•(6\) The tear volume of subject eye which measured by the Schirmer I method, in 5 minutes, the wet length of the test paper is 5 mm or more.
•(7\) The endothelial cell density of the cornea of the subject eye is 2,000 cells/mm2 or more.
•(8\) Persons who can have the scheduled medical examinations and follow the procedures without fail.
•(9\) Persons who can use the investigational device appropriately and to keep the necessary hygiene management for wearing the investigational device. In the case of minors, the guardian should be able to support the subject.
•(10\) Persons who have been wearing hard contact lenses should stop wearing for at least two weeks, and persons who have been wearing soft contact lenses should stop wearing for at least one week, before having the applicable examination. During the withdrawal period wearing eyeglasses is permitted.

Exclusion Criteria

•(1\) Patients with acute or subacute inflammation of the anterior eye segment
•(2\) Patients with ocular infections
•(3\) Patients with uveitis
•(4\) Patients with reduced corneal sensitivity.
•(5\) Patients with corneal epithelial defects
•(6\) Patients with eyelid abnormalities. However, if the investigator judged that the abnormality is not significant, the patient is permitted to participate in the clinical trial.
•(7\) Patients with severe lacrimation decreased (dry eye) or lacrimal apparatus disease
•(8\) Patients who have had an allergic reaction to the eye surface or eye accessory, or have had an exacerbation of such reaction, due to wearing contact lenses or using care products for contact lenses.
•(9\) Patients with systemic diseases affecting the eye or systemic diseases aggravated by orthokeratology lens wear.
•(10\) Patients with immune disorders (e.g., acquired immune deficiency syndrome, autoimmune disease) or diabetes mellitus