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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001964
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Ophthalmology, Saga University Faculty of Medicine
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002376

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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