MyDay MF Clinical Study

Not Applicable

• Conditions: presbyopia; D011305

• Registration Number: JPRN-jRCTs042210092
• Lead Sponsor: Kodama Yuji

Brief Summary

The study lens was superior in the following endpoints. (1) The overall evaluation score for near vision of the study lens was superior to that of the previous lenses. (2) As a result of the relative comparison between the study lens and the previous lens, the study lens was found to be superior in overall comparison of lenses by VAS, wearing feeling, distance/mid-distance/near vision, and overall vision.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-29
• Study Completion: 2022-07-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 109

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified