UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011319 |
|---|---|
| Receipt number | 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 16:48:43 |
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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
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
ksugi@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013204
