UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019291 |
|---|---|
| Receipt number | R000022311 |
| Scientific Title | Safety evaluation of albumin eye drop in patients with dry eye disease |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2016/02/10 11:24:12 |
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Basic information
Public title
Safety evaluation of albumin eye drop in patients with dry eye disease
Acronym
Safety evaluation of albumin eye drop
Scientific Title
Safety evaluation of albumin eye drop in patients with dry eye disease
Scientific Title:Acronym
Safety evaluation of albumin eye drop
Region
| Japan |
Condition
Condition
dry eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of 4 weeks topical administration of albumin eye drop (including 15% recombinant human serum albumin) in patients with dry eye disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
(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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
topical recombinant human serum albumin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Over 20 years
2 Definite dry eye disease diagnosed by Japanese dry eye diagnostic criteria
3 Severity of dry eye; Level 1- Level 4
Dry Eye WorkShop 2007 (DEWS 2007)
Key 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
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Ogawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 160-8582 Japan
TEL
0353633972
yoko@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yoko ogawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo 160-8582 Japan
TEL
+81353633972
Homepage URL
yoko@z7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
R-Tech Ueno, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022311
