UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015890 |
|---|---|
| Receipt number | R000018496 |
| Scientific Title | Survey of Dry eye patients at Ophthalmology clinics in Japan [Cross-sectional multicenter observational study ] Dry Eye Cross-sectional Study in Japan |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2015/12/21 11:45:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey of Dry eye patients at Ophthalmology clinics in Japan
[Cross-sectional multicenter observational study ]
Dry Eye Cross-sectional Study in Japan
Acronym
Dry Eye Cross-sectional Study in Japan [DECS-J]
Scientific Title
Survey of Dry eye patients at Ophthalmology clinics in Japan
[Cross-sectional multicenter observational study ]
Dry Eye Cross-sectional Study in Japan
Scientific Title:Acronym
Dry Eye Cross-sectional Study in Japan [DECS-J]
Region
| Japan |
Condition
Condition
Dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We can get the evidence to construct the new clinical guideline, to investigate dry eye diagnosis and treatment at local ophthalmology clinics in Japan.
Basic objectives2
Others
Basic objectives -Others
To investigate dry eye diagnosis and treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Evaluation items [averages, ratios]
2)Subject backgrounds[gender, age, history with contact lens, history with eye disease, history with ocular surgery]
3)Dry eye types
4)Treatment regimens and their ratio according to dry eye type.
5)QOL/Utility
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
1)Over 20years old
2)Out patients
3)Patients under dry eye treatment or who were diagnosed as definite and probable dry eye by 2006 diagnostic criteria for dry eye
Key exclusion criteria
1)Patient with a history of fluorescein hypersensitivity
2)Patients whom investigators determine are not eligible
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamada |
Organization
Kyorin university hospital
Division name
Department of ophthalmology
Zip code
Address
6-20-2 Shinkawa,Mitaka,Tokyo
TEL
0422-47-5511
yamada@eye-center.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamada |
Organization
Kyorin university hospital
Division name
Department of ophthalmology
Zip code
Address
6-20-2 Shinkawa,Mitaka,Tokyo
TEL
0422-47-5511
Homepage URL
yamada@eye-center.org
Sponsor or person
Institute
Dry eye society
Institute
Department
Personal name
Funding Source
Organization
Santen pharmaceutical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
北1条田川眼科（北海道）
赤坂東急クリニック島崎眼科（東京都）
医療法人社団慶翔会 両国眼科クリニック（東京都）
齋藤眼科医院（埼玉県）
いしだ眼科（静岡県）
医療法人社団 真医会 四条烏丸眼科 小室クリニック（京都府）
医療法人創正会 イワサキ眼科医院（大阪府）
松本眼科（徳島県）
はなみずき眼科（愛媛県）
きよさわ眼科（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Inclusion for Analysis: 449 cases (63 males,386 females,Age:62.6)
Dry Eye Diagnosis:Under treatment:Define dry eye 237 cases(52.8%),Probable dry eye 188 cases(41.9%),Newly Diagnosed:63cases(14.0%)
BUT 5 sec or under:426cases(94.9%),Schirmer's test 5 mm or under:245 cases(54.6%),kerato-conj.score3 or over:256 cases(57.0%)
Dry Eye Subtype:Aqueous deficiency(35.0%),short-BUT(26.7%)
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate dry eye diagnosis and treatment
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018496
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
