Clinical study of Myday

JRCT ID: jRCTs052180004

Registered date:27/08/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: myopia and myopic astigmatism
• Date of first enrollment: 31/08/2018
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Two types of contact lens wearing by quasi randomized trial.

Outcome(s)

• Primary Outcome: Evaluate the fitting of soft contact lenses.
• Secondary Outcome: Slit lamp findings, subjects answers to the questionnaires and corrected visual acuity will be evaluated at each visit.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 42age old
• Gender: Both

Include criteria

1.Individuals who are between 18 and 42 years old at the time of consent. However, for individuals under the age of 20, in addition to their informed consent, a written consent should be obtained from a parent or legal guardian.
2.Individuals who are wearing one day disposable SCL except "My Day" and "One Day Acuvue True Eye" in both eyes for longer than 8 hours a day and more than 5 days a week.
3.Individuals having 0.75 D or less astigmatism obtained by subjective refraction and no symptoms of presbyopia.
4.Individuals who wear SCL within the power range of the study CL (-2.00 to -7.00D).
5.Individuals with distant visual acuity equal to 1.0 or better for each eye, when corrected with spherical and cylindrical lenses.
6.Individuals who are able to read and understand the instruction of this study and provide signed informed consent.
7.Individuals who can visit the clinic as scheduled.
8.Individuals who have had eye examination at the eye clinic within the last two years.
9.Individuals who can limit wearing time between 8 hours and 16 hours per day.
10.Individuals with clear cornea and no active ocular disease.

Exclude criteria

1.Individuals with any systemic disease affecting ocular health.
2.Individuals who are pregnant or in the lactation period.
3.Individuals who are using any systemic or topical medications which could affect the result of the study.
4.Individual with infectious eye disease.
5.Individuals who have ocular or systemic allergy disease which could prevent from wearing SCL.
6.Individual who have medium to severe dry eye symptoms which could affect SCL wear.
7.Individuals who have clinically severe eye disease such as neovascularization, limbal hyperemia and corneal epithelial defects.
8.Individuals who have clinically severe disorder in the eyelid or conjunctiva.
9.Individuals with an aphakia or an intraocular lens.
10.Individuals who have worn Hard Contact Lenses within 30 days.
11.Individuals working in the clinic or the family members who are subject to conflict of interest with the following companies related to this study.
- Cooper Vision Japan, Inc
- Six Bleu Co., Ltd
- Ai Research, Inc
- Johnson & Johnson, Inc
12.Individuals who are participating in other clinical study.
13.Individuals who have had corneal refractive surgery.

Related Information

• Primary Sponsor: Kodama Yuji
• Source(s) of Monetary Support: CooperVision Japan, Inc.