Safety evaluation of albumin eye drop in patients with dry eye disease
Phase 1
- Conditions
- dry eye disease
- Registration Number
- JPRN-UMIN000019291
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
Exclusion Criteria
1 Severe systemic disease that may progress to more severe condition 2 Sjogren's syndrome, Ocular cicatricial pemphigoid, Graft-versus-host disease (GVHD) 3 History of eye surgery 4 Contact lens wearer 5 Irradiation during this clinical study 6 Oral treatment by Cevemeline and Pilocalpine 7 History of allergy on human serum protein or yeastferment 8 History of allergies to (1) substances contained recombinant materials, eye drops, and the investigational drug, and (2) solutions which are supposed to be used in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method (Ocular Surface index score; OSDI), Value of Schirmer test, fluorescein score, rose bengal score, underlying disease, duration from hematopoietic stem cell transplantation, stem cell sources of hematopoietic stem cell transplantation