UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002717 |
|---|---|
| Receipt number | 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 10:50:06 |
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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
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
Sponsor or person
Institute
Kyoto University Hospital
Department of Ophthalmology and visual sciences
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003135
