UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001526 |
|---|---|
| Receipt number | R000001842 |
| Scientific Title | Clinical trial of novel prostaglandin F2alpha derivative against glaucoma |
| Date of disclosure of the study information | 2008/11/26 |
| Last modified on | 2014/05/25 09:03:21 |
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Basic information
Public title
Clinical trial of novel prostaglandin F2alpha derivative against glaucoma
Acronym
Clinical trial of novel prostaglandin F2alpha derivative against glaucoma
Scientific Title
Clinical trial of novel prostaglandin F2alpha derivative against glaucoma
Scientific Title:Acronym
Clinical trial of novel prostaglandin F2alpha derivative against glaucoma
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test IOP reducing effect of prostaglandin F2alpha derivatives against glaucomatous eyes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP reducing effect of eye drops against glaucomatous eyes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical ocular hypotensive eye drops
Interventions/Control_2
Topical ocular hypotensive eye drops
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma or ocular hypertension
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Tanito |
Organization
Shimane University Faculty of Medicine
Division name
Ophthalmology
Zip code
Address
Enya 89-1, Izumo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
tanito-oph@umin.ac.jp
Sponsor or person
Institute
Departmet of Ophthalmology, Shimane 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
| 2008 | Year | 11 | Month | 26 | 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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | 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
| 2008 | Year | 11 | Month | 25 | Day |
Last modified on
| 2014 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001842
