UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001964 |
|---|---|
| Receipt number | R000002376 |
| Scientific Title | Ocular hypotensive effects of TAPROS ophthalmic solution 0.0015%. |
| Date of disclosure of the study information | 2009/05/14 |
| Last modified on | 2009/11/16 13:56:24 |
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Basic information
Public title
Ocular hypotensive effects of TAPROS ophthalmic solution 0.0015%.
Acronym
Ocular hypotensive effects of TAPROS ophthalmic solution 0.0015%.
Scientific Title
Ocular hypotensive effects of TAPROS ophthalmic solution 0.0015%.
Scientific Title:Acronym
Ocular hypotensive effects of TAPROS ophthalmic solution 0.0015%.
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate ocular hypotensive effects of TAPROS ophthalmic solution 0.0015% in Glaucoma patients, not enough hypotensive effect with other prostaglandin ophthalmic solution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure reduction,
% reduction of intraocular pressure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TAPROS ophthalmic solution 0.0015%
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients, over 18mmHg in intra ocular pressure, at least 4weeks Xalatan TM ophthalmic solution treatment and at least 4weeks Travatan z TM ophthalmic solution treatment.
2)Patients, without 20% ocular hypotensive effects, at least 4weeks Xalatan TM ophthalmic solution treatment and at lease 4weeks Travatan z TM ophthalmic solution treatment.
3)Patients, be graded under stage4 at Kozaki's classification.
Key exclusion criteria
1)Presence of any external disease and inflammation of the eye.
2)History of intraocular surgery within one month.
3)Patients with Drug-induced hypersensitivity syndrome.
4)Patients with maintain over 35mmHg in intraocular pressure over one week.
5) The investigator declares any subject ineligible for any sound medical reason.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiniciro Ishikawa |
Organization
Saga University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Nabeshima 5-1-1, Saga, Saga, 849-8501
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saga University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Nabeshima 5-1-1, Saga, Saga, 849-8501
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Saga University Faculty of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 14 | 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
| 2008 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 13 | Day |
Last modified on
| 2009 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002376
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
