JRCT ID: jRCTs061180036
Registered date:04/03/2019
Clinical efficacy of FGLM-NH2+SSSR eye drops for intractable corneal epithelial disorders
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Persistent epithelial defect |
Date of first enrollment | 18/11/2006 |
Target sample size | 165 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | In cases of persistent corneal epithelial defect, FGLM-NH2+SSSR eye drops are instilled four times a day (in the morning, afternoon, evening, before going to bed). One dose is 1 drop. The administration period is 4 weeks. However, for Case in which corneal epithelial defect persists, the administration period can be extended up to 8 weeks. Regarding combination therapy that has already been conducted for persistent corneal epithelial defect, eye drops and treatments considered to promote corneal epithelial wound healing such as sodium hyaluronate eye drops and soft contact lens wearing can be used together. But the changes shall not be accepted in principle within the research period. |
Outcome(s)
Primary Outcome | Time to complete healing for persistent epithelial defect |
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Secondary Outcome | Visual acuity Safety |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1.The presence of persistent epithelial defect by slit-lamp examination resistant to conventional treatments for more than 1 week 2.male and female 3.age >= 20years 4.Patients provided written, informed consent to participate |
Exclude criteria | 1. Are pregnant or may possibly be pregnant 2. In breast-feeding women 3. Drug allergies for this agents 4. Were judged an inadequate subject to enrollment by a medical doctor |
Related Information
Primary Sponsor | Kimura Kazuhiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN0000026871 |
Contact
Public contact | |
Name | Naoyuki Yamada |
Address | 1-1-1,MinamiKogushi,Ube City Yamaguchi Japan 755-8505 |
Telephone | +81-836-22-2278 |
n.yamada@yamaguchi-u.ac.jp | |
Affiliation | Yamaguchi University Hospital |
Scientific contact | |
Name | Kazuhiro Kimura |
Address | 1-1-1,MinamiKogushi,Ube City Yamaguchi Japan 755-8505 |
Telephone | +81-836-22-2278 |
adminoph@yamaguchi-u.ac.jp | |
Affiliation | Yamaguchi University Hospital |