UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000893 |
|---|---|
| Receipt number | R000001075 |
| Scientific Title | Intraocular pressure lowering effect of latanoprost for glaucomatous patients with trabeculectomy |
| Date of disclosure of the study information | 2007/11/15 |
| Last modified on | 2013/05/30 11:27:34 |
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Basic information
Public title
Intraocular pressure lowering effect of latanoprost for glaucomatous patients with trabeculectomy
Acronym
Latanoprost after trabeculectomy
Scientific Title
Intraocular pressure lowering effect of latanoprost for glaucomatous patients with trabeculectomy
Scientific Title:Acronym
Latanoprost after trabeculectomy
Region
| Japan |
Condition
Condition
Patients with open-angle glaucoma after trabeculectomy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether latanoprost lowers intraocular pressure in eyes with trabeculectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.005% latanoprost, once daily for 6 months
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with open-angle glaucoma.
Intraocular pressure level of 15 mmHg or higher.
Within 12 months after trabeculectomy.
Key exclusion criteria
Patients with contraindication for the use of latanoprost.
Patients with incapable measurement of intraocular pressure due to corneal diseases.
Patients with intraocular inflammation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-1-1 Honjo Kumamoto, 860-8556 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-1-1 Honjo 8608556 Kumamoto Japan
TEL
096-373-5247
Homepage URL
Sponsor or person
Institute
Kumamoto University
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
| 2007 | Year | 11 | Month | 15 | 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
| 2007 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2007 | Year | 11 | Month | 15 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001075
