臨床研究等提出・公開システム

Comparison of Silicone Hydrogel Daily Disposable Multifocal Contact Lens (MyDay daily disposable Multifocal)
and Habitually Worn Soft Contact Lenses in Presbyopic Patients

MyDay MF Clinical Study

109

The mean age of the 109 patients enrolled in the study was 51.2 years (lowest: 43 years, highest: 64 years). Gender: 5 males (4.6%) and 104 females (95.4%). History of ophthalmic surgery: 1 case, ocular complications: 2 cases, and complications of allergic diseases: 10 cases were observed, but none of them had any problems with lens wear. The most common lifestyle habits in the study subjects' daily lives were, in descending order, cell phone/smart phone use (96.3%), housework (93.6%), driving a car or motorcycle (74.3%), computer use (69.7%), and close work such as desk work (62.4%). The proportion of the eyes corrected with a spherical power of -3.00D to -5.75D in the previous lenses was 63.9% for 1day disposable single vision lenses, 48.4% for multifocal silicone hydrogel lenses, and 45.7% for multifocal hydrogel lenses. Moderate myopias were observed the most in this study subjects. The percentage of CL corrected patients with binocular distance visual acuity of 1.0 or better was 85.2% for the 1day disposable single vision lenses, 96.9% for the multifocal silicone hydrogel lenses, and 91.3% for the multifocal hydrogel lenses, while the percentage of CL corrected patients with binocular near visual acuity of 1.0 or better was 33.3% for the 1day disposable single vision lenses, 34.4% for multifocal silicone hydrogel lenses, and 21.7% for multifocal hydrogel lenses.

2021/10/21: Approved by Kanazawa Medical University IRB 2021/10/26: Newly registered in jRCT 2021/11/18: First case enrolled 2022/02/28: Final case enrollment (the 32nd case) in the multifocal silicone hydrogel lens group 2022/04/27: Study period was extended to 2023/06/30 to attain the target number of patients 2022/05/19: Final case enrollment (the 54th case) in the 1day disposable single vision lens group 2022/06/14: Final case enrollment (the 23rd case) in the multifocal hydrogel lens group 2022/07/11: Observation of the final case was completed 2022/08/19: Principal investigator reviewed all the cases and fixed the data

Seven minor and non-serious adverse events were observed in six patients. In these 7 cases, "foreign body sensation (both eyes)" was found to have a relationship with the study lens, "superficial punctate keratitis (both eyes)" and "subconjunctival hemorrhage (right eye)" were unknown cause, and the other four cases of "subconjunctival hemorrhage (right eye)," "poor physical condition," "chalazion (right eye)" and "Upper eyelid meibomian gland infarction (left eye)" were all evaluated as not related to the study lens. One case of "liquid leakage" was reported, but no adverse events were observed due to this problem.

Primary endpoint: Overall satisfaction with the study lens as measured by the Visual Analog Scale (VAS) The mean +/- standard deviation of the VAS value at Visit 4 (overall satisfaction with the study lens) minus the VAS value at Visit 2 (overall satisfaction with the previous lens) for the 109 study subjects was 0.74 +/- 25.90, with a median (interquartile range) was 1.0 (23.0). A histogram was generated and a Shapiro-Wilk normality test was performed. p=0.0034 was obtained, so the Wilcoxon signed rank test was used. The results of this two-tailed test showed that p=0.5589, which did not prove the superiority of overall satisfaction with the study lens compared to the previous lens. The results of the subgroup analysis also failed to prove the superiority of overall satisfaction with the study lens compared to any of the previous lenses. Secondary endpoint: Overall evaluation score for ease of handling the study lens The median (interquartile range) of the overall evaluation score in Visit 4 (ease of handling the study lens) minus the overall evaluation score in Visit 2 (ease of handling the previous lens) for the 108 study subjects (excluding one who did not complete the questionnaire) was 0.0 (1.0). The median (interquartile range) of 0.0 (1.0) was not larger than that of the previous lenses, so the overall evaluation score for the ease of handling of the study lenses did not prove superiority over the previous lenses. Subgroup analysis also showed that the overall rating score for ease of handling of the study lens did not prove superiority compared to any of the previous lenses.

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.

Dec. 26, 2022

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs042210092

Kodama Yuji

Kodama Eye Clinic

15-459 Terada Mitosaka, Joyo City, Kyoto

yuji@kodama.or.jp

Kodama Yuji

Kodama Eye Clinic

15-459 Terada Mitosaka, Joyo City, Kyoto, Japan

+81-774-53-2003

yuji@kodama.or.jp

Complete

Oct. 29, 2021

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

presbyopia

Wearing study lenses "MyDay MF"

D011305

Overall satisfaction for study lens

Overall satisfaction for lens handling of study lens

+81-76-218-8346

Oct. 21, 2021

none