UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004596 |
|---|---|
| Receipt number | R000005489 |
| Scientific Title | Evaluation of dorzolamide/timolol fixed combination therapy for the patients who need more IOP reduction under PG analogues |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2013/11/21 16:24:49 |
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Basic information
Public title
Evaluation of dorzolamide/timolol fixed combination therapy for the patients who need more IOP reduction under PG analogues
Acronym
Evaluation of dorzolamide/timolol fixed combination therapy
Scientific Title
Evaluation of dorzolamide/timolol fixed combination therapy for the patients who need more IOP reduction under PG analogues
Scientific Title:Acronym
Evaluation of dorzolamide/timolol fixed combination therapy
Region
| Japan |
Condition
Condition
primary open angle glaucoma, ocular hypertension
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dorzolamide/timolol fixed combination therapy for the patients with uncontrolable IOP under PG analogues
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure, ocular and general side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Additive administration of dorzolamide/timolol fixed combination therapy
Interventions/Control_2
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) primary open angle glaucoma, ocular hypertension
2) inadequate IOP reduction under PG drugs for more than 2 months
Key exclusion criteria
1) patients who received any surgical therapy within the past 3 months (incl. laser surgery)
2) difficult to measure IOP with GAT
3) difficult to check the fundus due to the corneal opacity or cataract
4) any patients who are expected to receive any surgical procedures during the study periods
5) contraindication of beta blockers or dorzolamide
6) any allergic history to the timilol or dorzolamide
7) women who are under pregnant or lactation period
8) any one who is considered to be inappropriate for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Mori |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Kawaramachi Hitokouji, Kamigyoku, Kyoto 602-0841, JAPAN
TEL
075-251-5578
kmori@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Mori, Morio Ueno, Yoko Ikeda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Kawaramachi Hitokouji, Kamigyoku, Kyoto 602-0841, JAPAN
TEL
075-251-5575
Homepage URL
kmori@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kyoto Prefectural University of Medicine
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 | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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 | 11 | Month | 21 | Day |
Last modified on
| 2013 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005489
