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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002717
Receipt No. R000003135
Scientific Title Study of low-responder to Tafluprost ophthalmic solution and Latanoprost ophthalmic solution
Date of disclosure of the study information 2010/01/01
Last modified on 2011/05/06

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Basic information
Public title Study of low-responder to Tafluprost ophthalmic solution and Latanoprost ophthalmic solution
Acronym Study of low-responder to Tafluprost ophthalmic solution and Latanoprost ophthalmic solution
Scientific Title Study of low-responder to Tafluprost ophthalmic solution and Latanoprost ophthalmic solution
Scientific Title:Acronym Study of low-responder to Tafluprost ophthalmic solution and Latanoprost ophthalmic solution
Region
Japan

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

Objectives
Narrative objectives1 To investigate effects of Taflurost and Latanoprost on intraocular pressure lowering rate, low-responder to each ophthalmic solution and safety in glaucoma and ocular hypertension in randomized, open-labeled, crossover, study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy: Intraocular Pressure Lowering rate
Key secondary outcomes Intraocular Pressure
Safety

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After more than 4weeks of washout period, instill Tafluprost for 8 weeks. Then 4 weeks of second washout period, instill Latanoprost for 8weeks.
Interventions/Control_2 After more than 4weeks of washout period, instill Latanoprost for 8 weeks. Then 4 weeks of second washout period, instill Tafluprost for 8weeks.
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) Diagnosed with primary open angle glaucoma or ocular hypertension, and being receiving monotherapy or no-treatment.
2) Intraocular pressure is more than 16 mmHg without treatment or more than 13 mmHg with monotherapy treatment.
3) Over 20 years old on the date of agreement.
4) Both male and female
5) Outpatient care
6) Subjects whose agreement was shown by him/herself.
Key exclusion criteria 1) Having any hypersensitivity to test drugs.
2) Having severe visual field defect (HFA <-15dB)
3) Having absolute scotoma within 5 degrees in the center of the visual field.
4) Having any corneal abnormality or other condition preventing reliable applanation tonometry.
5) Having history of glaucoma surgery.
6) Having history of cataract surgery within 1 year.
7) Having history of refractive surgery.
8) Presence of any external ocular disease, inflammation or infection of the eye and/or eyelids.
9) Subjects need to be treated with corticosteroid during study period.
10) Pregnant subjects and subjects suspected of being pregnant
11) Subjects investigators declare ineligible for any sound medical reason
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Hangai
Organization Kyoto University Hospital
Division name Department of Ophthalmology and visual sciences
Zip code
Address 54 Kawara-cho Seigoin Sakyuo-ku Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Nonaka
Organization Kyoto University Hospital
Division name Department of Ophthalmology and visual sciences
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kyoto University Hospital
Department of Ophthalmology and visual sciences
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
2010 Year 01 Month 01 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 Terminated
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 05 Day
Last modified on
2011 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003135

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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