UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006007 |
|---|---|
| Receipt number | 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 16:43:33 |
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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
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
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007062
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
