UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024370 |
|---|---|
| Receipt number | R000028031 |
| Scientific Title | Biochemical analysis of tear composition in dry eye patients |
| Date of disclosure of the study information | 2016/10/17 |
| Last modified on | 2021/10/16 09:09:34 |
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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 | Masakazu |
| Middle name | |
| Last name | Yamada |
Organization
Kyorin University School of Medicine
Division name
Department of Ophthalmology
Zip code
1818611
Address
Shinkawa,
TEL
0422475511
yamada@eye-center.org
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Shigeyasu |
Organization
Kyorin University School of Medicine
Division name
Department of Ophthalmology
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
shigeyasu@eye-center.org
Sponsor or person
Institute
Department of Ophthalmology, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Kyorin University School of Medicine
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
Kyorin University School of Medicine
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
irb@ks.kyorin-u.ac.jp
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
| 2016 | Year | 10 | Month | 17 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since it is a study using the normally performed Schirmer test, there have been no trouble carrying out the study. However, the patient registration are needed to be increased.
Management information
Registered date
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028031
