UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025752 |
|---|---|
| Receipt number | R000029625 |
| Scientific Title | Biochemical analysis of tear composition in dry eye patients |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2017/01/19 19:47:51 |
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Basic information
Public title
Biochemical analysis of tear composition in dry eye patients
Acronym
Biochemical analysis of tear composition
Scientific Title
Biochemical analysis of tear composition in dry eye patients
Scientific Title:Acronym
Biochemical analysis of tear composition
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the tear compostion, including tear proteins and lipids, in patients with dry eye
Basic objectives2
Others
Basic objectives -Others
To investigate the composition which plays a role in pathophysiology of dry eye, which may lead to future treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tears are colloected by Schirmer test strips from the dry eye patints, which are clinically performed. After the elution of tear protein and lipid, total protein and lactoferrinm lipocalin, lysozyme and secretory IgA are measured. And cytokines, phospholipase A2, lipids are fractioned and quantified.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Dry eye patients
(defined by the diagnostic criteria of Japan dry eye society 2006)
Key exclusion criteria
1) Complication of anterior disease(blepharitis, lagophthalmos, blepharospasm and iritis) other than dry eye ( patients with past history of the above disease are included).
2) Patients who were assessed as inadequate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamada |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division for Vision Research, National Institute of Sensory Organs
Zip code
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8982 Japan
TEL
03-3411-0379
yamada@eye-center.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chika Shigeyasu |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Division for Vision Research, National Institute of Sensory Organs
Zip code
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8982 Japan
TEL
03-3411-0379
Homepage URL
shigeyasu@kankakuki.go.jp
Sponsor or person
Institute
Department of Ophthalmology, National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, National Institute of Sensory Organs, National Hospital Organization Tokyo Medical Center
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 01 | Month | 20 | 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
Date of protocol fixation
| 2010 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is a study using Schirmer test, which is normally performed in dry eye patients.
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2017 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029625
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