NIPH Clinical Trials Search

JRCT ID: jRCTs042210092

Registered date:29/10/2021

MyDay MF Clinical Study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedpresbyopia
Date of first enrollment18/11/2021
Target sample size119
Countries of recruitment
Study typeInterventional
Intervention(s)Wearing study lenses "MyDay MF"


Primary OutcomeOverall satisfaction for study lens
Secondary OutcomeOverall satisfaction for lens handling of study lens

Key inclusion & exclusion criteria

Age minimum>= 42age old
Age maximumNot applicable
Include criteria1) He/she is at least 42 years of age when giving his/her informed consent 2) He/she is presbyopia 3) He/she habitually wears any of the following SCLs for at least 8 hours a day, 5 days a week until he/she gave consent - Daily disposable sphere soft contact lenses (Any brand) - Multifocal silicone hydrogel lenses "Dailies Total 1 MF" - Multifocal hydrogel lenses "Proclear 1 Day MF" 4) He/she can achieve a corrected distance visual acuity of at least 0.9 (decimal visual acuity) in each eye through refractive correction with spherocylindrical lenses 5) He/she has sphere power of +3.00~-8.00 when taking into account vertex distance 6) He/she has refractive astigmatism (cylindrical power) no higher than 1.00D from a manifest refraction 7) He/she requires a reading addition of at least +0.75D and no more than +2.50D from a manifest refraction 8) He/she is willing to undergo a medical examination on the specified examination date 9) He/she understood the information sheet and was able to give his/her voluntary written consent.
Exclude criteria1) He/she has worn hard contact lenses within 30 days before giving his/her consent 2) He/she has undergone refractive error surgery 3) He/she who has had an aphakic intraocular or intraocular lens implanted in his/her eye(s) 4) He/she is evaluated by slit lamp to have anterior ocular complications evaluated to be 3 or higher on the Efron Grading Scales 5) He/she is not satisfied with his/her visual quality with a single adjustment to sphere power of study lenses at baseline 6) He/she who has the following ophthalmic diseases - Acute and subacute inflammation of the anterior chamber of the eye - Ocular infection - Uveitis - Decreased corneal sensitivity - Eyelid abnormalities 7) He/she who has dry-eye symptoms and lacrimal apparatus disease to an extent that may cause issues in wearing lenses 8) He/she who has allergic diseases that may impact wearing lenses 9) He/she who usually resides in a dry environment 10) He/she who resides in an environment where dust and chemicals, etc. easily enter the eyes 11) He/she who is unable to follow the physician's instructions 12) He/she who is unable to use the lenses in an appropriate manner 13) He/she who is unable to follow lens care regimen 14) She self-reports as pregnant, lactating, or taking oral contraceptives 15) He/she who is participating in other clinical trials or studies 16) Anyone who is determined by the Co-Principal Investigators or others to be ineligible for this study.

Related Information


Public contact
Name Yuji Kodama
Address 15-459 Terada Mitosaka, Joyo City, Kyoto, Japan Kyoto Japan 610-0121
Telephone +81-774-53-2003
Affiliation Kodama Eye Clinic
Scientific contact
Name Yuji Kodama
Address 15-459 Terada Mitosaka, Joyo City, Kyoto Kyoto Japan 610-0121
Telephone +81-774-53-2003
Affiliation Kodama Eye Clinic