NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedPersistent epithelial defect
Date of first enrollment18/11/2006
Target sample size165
Countries of recruitment
Study typeInterventional
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 OutcomeTime to complete healing for persistent epithelial defect
Secondary OutcomeVisual acuity Safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1.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 criteria1. 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

Contact

Public contact
Name Naoyuki Yamada
Address 1-1-1,MinamiKogushi,Ube City Yamaguchi Japan 755-8505
Telephone +81-836-22-2278
E-mail 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
E-mail adminoph@yamaguchi-u.ac.jp
Affiliation Yamaguchi University Hospital