UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003182 |
|---|---|
| Receipt number | R000003859 |
| Scientific Title | A prospective investigation of the effect with Lomerizine on visual field damage in eyes with glaucoma |
| Date of disclosure of the study information | 2010/02/17 |
| Last modified on | 2013/07/11 18:05:09 |
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Basic information
Public title
A prospective investigation of the effect with Lomerizine on visual field damage in eyes with glaucoma
Acronym
The effect with Lomerizine on visual field damage
Scientific Title
A prospective investigation of the effect with Lomerizine on visual field damage in eyes with glaucoma
Scientific Title:Acronym
The effect with Lomerizine on visual field damage
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively study the effect of oral lomerizine, a Ca2+ channel blocker, on further visual field damage in patients with glaucoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual field
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Intervention group. Period 3years, Amount Lomerizine hydrochloride 5mg, Frequency 2 times per day
Interventions/Control_2
Control group. Period 3years, Amount methylcobalamin 500ug, Frequency 3 times per day
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. Open angle glaucoma.
2. IOP with anti-glaucoma eye drops not exceeding 17mmHg.
Key exclusion criteria
1. Having history of severe diabetes mellitus and cardiac disease etc.
2. Having administration of calcium channel blocker.
3. Having ocular diseases other than glaucoma.
4. Having history of intraocular surgery and laser surgery within 12 months.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Chiba |
Organization
University of Yamanashi
Division name
Depertment of Ophthalmology
Zip code
Address
1110 shimokato chuo yamanashi Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Yamanashi
Division name
Depertment of Ophthalmology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Yamanashi, Depertment of Ophthalmology
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 | 02 | Month | 17 | 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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 14 | Day |
Last modified on
| 2013 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003859
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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