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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004596
Receipt No. 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

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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
Email 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
Email kmori@koto.kpu-m.ac.jp

Sponsor
Institute Department of Ophthalmology, Kyoto Prefectural University of Medicine
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005489

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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