MyDay MF Clinical Study

JRCT ID: jRCTs042210092

Registered date:29/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: presbyopia
• Date of first enrollment: 18/11/2021
• Target sample size: 119
• Study type: Interventional
• Intervention(s): Wearing study lenses "MyDay MF"

Outcome(s)

• Primary Outcome: Overall satisfaction for study lens
• Secondary Outcome: Overall satisfaction for lens handling of study lens

Key inclusion & exclusion criteria

• Age minimum: >= 42age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Kodama Yuji
• Secondary Sponsor: Chikara Saito,CooperVision Japan Inc.