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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006007
Receipt No. R000007062
Scientific Title Comparison of efficacy between fixed combination of latanoprost/timolol + dorzolamide and fixed combination of dorzolamide/timolol + latanoprost in glaucoma patients with a histry of treatment with three unfixed eyedrops.
Date of disclosure of the study information 2011/07/21
Last modified on 2013/06/24

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Basic information
Public title Comparison of efficacy between fixed combination of latanoprost/timolol + dorzolamide and fixed combination of dorzolamide/timolol + latanoprost in glaucoma patients with a histry of treatment with three unfixed eyedrops.
Acronym Comparison of efficacy between two different fixed combination eyedrops.
Scientific Title Comparison of efficacy between fixed combination of latanoprost/timolol + dorzolamide and fixed combination of dorzolamide/timolol + latanoprost in glaucoma patients with a histry of treatment with three unfixed eyedrops.
Scientific Title:Acronym Comparison of efficacy between two different fixed combination eyedrops.
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare intraocular pressure-lowering efficacy between fixed combination of latanoprost/timolol + dorzolamide and fixed combination of dorzolamide/timolol + latanoprost.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intraocular pressure
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 Eye drops of fixed combination of latanoprost/timolol + dorzolamide.
Tree-month observation.
Interventions/Control_2 Eye drops of fixed combination of dorzolamide/timolol + latanoprost.
Tree-month observation.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with primary open-angle glaucoma whose intraocular pressures are controlled by unfixed combination of latanoprost, timolol, and dorzolamide/brinzolamide.
Key exclusion criteria 1) Patients with contraindication or careful administration in adopted eye drops.
2) MD value <-15 dB in Humphrey visual field analyzer.
3) Best corrected visual acuity <0.5.
4) Spherical equivalent <-9D or >9D.
5) Difference of spherical equivalent between right and left eye >3D
6) Patients with corneal abnormality that hinders intraocular pressure-measurement.
7) Insufficient mydriasis that inhibit observation of optic nerve disc.
8) Histry of ocular surgery and/or laser treatment except cataract surgery.
9) Retinal disease that affect visual field.
10) Patients who are considerd as appropriate by doctors in charge.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenobu Tanihara
Organization Kumamoto University
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto University
Division name Department of Ophthalmology and Visual Science
Zip code
Address
TEL 096-373-5247
Homepage URL
Email

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2011 Year 07 Month 21 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
2011 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 Year 06 Month 24 Day
Date of closure to data entry
2013 Year 06 Month 24 Day
Date trial data considered complete
2013 Year 06 Month 24 Day
Date analysis concluded
2013 Year 06 Month 24 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 20 Day
Last modified on
2013 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007062

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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