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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012411
Receipt No. R000014465
Scientific Title A prospective observational study of structure and visual field progression in open-angle glaucoma
Date of disclosure of the study information 2013/11/29
Last modified on 2016/09/27

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Basic information
Public title A prospective observational study of structure and visual field progression in open-angle glaucoma
Acronym A prospective observational study of structure and visual field progression in open-angle glaucoma
Scientific Title A prospective observational study of structure and visual field progression in open-angle glaucoma
Scientific Title:Acronym A prospective observational study of structure and visual field progression in open-angle glaucoma
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate progression and correlation of structure and visual field in glaucoma patients
Basic objectives2 Others
Basic objectives -Others Structure and visual field progression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MD
Retinal nerve fiber layer
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 Subject who is willing to follow instruction, and has provided a written informed consent
Diagnosis of open-angle glaucoma with glaucomatous visual field disorder in at least one eye
In both eyes, gonioscopy grading of 3 or 4 in Shaffer classification
Key exclusion criteria Subject who has a disease which considered inappropriate from safety perspective(severe cardiovascular/ respiratory/ hepatobiliary/ digestive/ urinary/ renal/ hematological/ endocrine/ immune disease, malignant tumor, etc.)
The investigator, subinvestigator determined that the person is ineligible as study subject
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenobu Tanihara
Organization Faculty of Life Science,
Kumamoto University
Division name Department of Ophthalmology
Zip code
Address 1-1-1, Honjo Chuo-ku Kumamoto Japan
TEL 096-373-5247
Email tanihara@pearl.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Kawata
Organization Santen Pharmaceutical CO., LTD.
Division name Clinical Development Group
Zip code
Address 4-20, Ofukacho Kita-ku Osaka Japan
TEL 06-4802-9338
Homepage URL
Email clinical@santen.co.jp

Sponsor
Institute Santen Pharmaceutical CO., LTD.
Institute
Department

Funding Source
Organization Santen Pharmaceutical CO., 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
Email

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
2013 Year 11 Month 29 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 No longer recruiting
Date of protocol fixation
2010 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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 A prospective observational study

Management information
Registered date
2013 Year 11 Month 27 Day
Last modified on
2016 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014465

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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