UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000425 |
|---|---|
| Receipt number | R000000516 |
| Scientific Title | Comparison of latanoprost and timolol in the treatment for exfoliation glaucoma: A randomized controlled trial. |
| Date of disclosure of the study information | 2006/06/30 |
| Last modified on | 2013/05/30 11:24:31 |
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Basic information
Public title
Comparison of latanoprost and timolol in the treatment for exfoliation glaucoma: A randomized controlled trial.
Acronym
Comparison of latanoprost and timolol for exfoliation glaucoma.
Scientific Title
Comparison of latanoprost and timolol in the treatment for exfoliation glaucoma: A randomized controlled trial.
Scientific Title:Acronym
Comparison of latanoprost and timolol for exfoliation glaucoma.
Region
| Japan |
Condition
Condition
Exfoliation glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By examining the effect and the safety of latanoprost and timolol, the first choice drug will be determined in the treatment for exfoliation glaucoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure after 3 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Latanoprost 1 per day for 3 months
Interventions/Control_2
Timolol 2 per day for 3 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Glaucoma patients with exfoliation material on the lens surface or the pupillary margin.
2. The eyes with the visual acuity of 0.1 or higher.
3. Written informed consent from the patient..
Key exclusion criteria
1. Severe visual field defect.
2. The treatment with latanoprost or timolol within the last 28 days.
3. Allergy to latanoprost or timolol.
4. The past histories of intraocular surgery within the last 3 months or glaucoma surgery.
5. The patients with asthma, heart failure, severe diabetes mellitus or pregnancy.
6. The patients who participated in another drug study within 30 days.
7. Judged inappropriate for this study by the physicians.
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
1-1-1Honjo Kumamoto, 860-8556 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
TEL
Homepage URL
inatani@u-fukui.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Kumamoto University Graduate School of Medical 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
| 2006 | Year | 06 | Month | 30 | 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
| 2005 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | 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
| 2006 | Year | 05 | Month | 30 | 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=R000000516
