Wear Study of "clariti 1 day"

JRCT ID: jRCT1032200350

Registered date:05/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: myopia and myopic astigmatism
• Date of first enrollment: 05/02/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Replacing contact lenses

Outcome(s)

• Primary Outcome: The primary endpoint is "handling" in the subject questionnaire at each visit.
• Secondary Outcome: Fitting tests at each visit and items other than handling in the subject questionnaire are defined as secondaryendpoints.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Subjects aged 18 years or older at the time of informed consent. However, if the subject is a minor (younger than 20 years), written informed consent should be obtained from his/her parent (legal representative).
2.Subjects who understand the purpose of this study and sign the informed consent form to participate in this study
3.Subjects who wear SCLs every day and agree to use the study lens as a 1-day disposable lens
4.Subjects to whom the study lens can be prescribed within its power range
5.Subjects who can comply with the method of use and visit the medical institution in accordance with the specified schedule
6.Subjects who wear daily disposable hydrogel SCLs other than the products marketed by the sponsor in Japan
7.Subjects who have no abnormal findings that would be problematic for CL wearing in the anterior eye

Exclude criteria

1.Subjects who plan to wear the lens for monocular vision or use the lens only for 1 eye
2.Subjects with aphakia or eyes implanted with artificial intraocular lenses
3.Subjects with systemic disease that may affect the eyes
4.Subjects who are using drugs that may affect the visual function and performance of the study lens
5.Subjects with corneal infiltration or corneal ulcer
6.Subjects who have undergone corneal surgery (refractive surgery, etc.)
7.Subjects who are participating in other clinical studies or researches
8.Other subjects who are judged to be inappropriate by the investigator

Related Information

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