Safety of Ocuring

JRCT ID: jRCTs012210037

Registered date:01/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 15/12/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Employing unapproved medical device

Outcome(s)

• Primary Outcome: Discontinuation rate while wearing Ocuring

Secondary Outcome

1. Success rate of wearing Ocuring
And changes in the following data during Ocuring wearing period
2. Objective refraction
3. Intraocular pressure
4. Visual acuity
5. Tear secretion function
6. Corneal shape
7. Corneal thickness
8. Tear film break-up time

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Men and women who understand the contents of the consent explanation document and their written informed consents can be obtained
2. Healthy volunteers whose age at the time of obtaining consent is 20 years or older

Exclude criteria

1. Those who currently have eye diseases
2. Those who have a history of eye surgery
3. Those who are judged to be unsuitable for Ocuring wear by the investigators
4. In addition, those who are judged to be ineligible as subjects of this study by the investigators

Related Information

• Primary Sponsor: Yoshiaki Tagawa
• Source(s) of Monetary Support: SEED Co., Ltd.