Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062067) titled 'Wearing study of HOYA 1-day contact lenses MF' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Dogenzaka Itoi Eye Clinic
Condition:
Condition - Myopia and Presbyopia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the wearing comfort of HOYA 1-day contact lenses MF in Japanese people who are currently wearing daily disposable MF contact lenses.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Wearing HOYA 1-day contact lenses MF for 7 days
Eligibility:
Age-lower limit - 38
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1)Be aged 38 years or more
2)Wearing daily disposable soft contact lenses MF in both eyes for at least 3 months and 5 days a week
3)No problems have occurred that would require the discontinuation of habitual contact lenses
4)Contact lens sphere requirement between -1.00 to -6.00 D
5)Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes
6)Be correctable by sphero-cylindrical refraction to 0.8 decimal or better in both eyes
7)Be correctable by near visual acuity to 0.6 decimal or better in both eyes
8)Be able to answer questionnaires and be able to visit the hospital on the designated day
9)After being fully informed about participation in this research, sufficient understanding is obtained, and the patient's voluntary written consent is obtained
Key exclusion criteria - 1)Corresponding to the contraindications/prohibitions described in the IFU of the test lens
2)Have a disease or any systemic illness that the investigator considers may interfere with contact lens wear
3)Eye disease other than refractive error (glaucoma, cataract etc.)
4)Investigator or subject considers fit, visual acuity, or handling of habitual lenses unacceptable (not stable to wear)
5)Investigator or subject determines that the fit or visual acuity with the study lens is unacceptable
6)Investigator judged that it was inappropriate as a research subject
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 26 Day
Date of IRB - 2026 Year 06 Month 22 Day
Anticipated trial start date - 2026 Year 07 Month 13 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071018
Disclaimer: Curated by HT Syndication.