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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000425
Receipt No. 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

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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
Email

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
Email inatani@u-fukui.ac.jp

Sponsor
Institute Department of Ophthalmology and Visual Science, Kumamoto University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000516

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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