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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011319
Receipt No. R000013204
Scientific Title Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.
Date of disclosure of the study information 2013/07/30
Last modified on 2014/03/26

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Basic information
Public title Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.
Acronym Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.
Scientific Title Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.
Scientific Title:Acronym Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary angle Glaucoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Ocular blood flow
Key secondary outcomes Intraocular pressure

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 Eye drops of tapuros (once daily) for one month. Then add detantole (twice daily) for next one month.
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) Both eyes was diagnosed glaucoma and untreatmented more than one month.
2) Subject eye is primary open angle glaucoma atleast.And fellow eye can undergo the treatment during test period
3) Outpatients or inpatients.
4) Patients who agreed and signed to the participation in this study.
5) Patients who can observed the schedule written in trial implementation protocol.
6) IOP(fellow eye)<=30
Key exclusion criteria 1) Patients who have ocular diseases without glaucoma and mild cataract(diabates retinopathy or morbid myopia or etc)
2) Progressive or severe glaucoma(for example using a Humphery field analyzer,MD <-12dB,0dB detection is in 5degree)
3) Patients with any corneal abnormality or other condition preventing reliable applanation tonometry.
4) Patients with anamnestic hitory of hypersensitivity to prostagrandin analogs and benzalkonium chloride.
5) Patients with active external ocular diseases,ocular inflammation or infection.
6) Patients with history of reflactive surgery.
7) Patients with history of internal ocular surgery within 6month before the study (cataract surgery,SLT,trabecrctomy,trabecrotomy etc).
8) Smoker
9) Patients who are unable to undergo ocular blood flow test.
10) Pregnant,lactating women ,the women who desired of the pregnancy during the test period.
11) Patients who are going to use prohibited drugs during test period.
12) Doctor judged to be inelible to the study.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Sugiyama
Organization Kanazawa University
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2403
Email ksugi@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa Sugiyama
Organization Kanazawa University
Division name Department of Ophthalmology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2403
Homepage URL
Email ksugi@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kanazawa University
Institute
Department

Funding Source
Organization None
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
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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 30 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
Instillation of tafluprost significantly reduced intraocular pressure, but there was no change in microcirculation of optic disc.
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
2009 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 19 Day
Last follow-up date
2009 Year 11 Month 04 Day
Date of closure to data entry
2009 Year 11 Month 04 Day
Date trial data considered complete
2009 Year 11 Month 04 Day
Date analysis concluded
2009 Year 11 Month 08 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 30 Day
Last modified on
2014 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013204

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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