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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007042
Receipt No. R000008303
Scientific Title Efficacy and Adherence of Xalacom Combination Therapy in Glaucoma Patients Switching from a Multi-Drug Therapy (PG and beta blocker medication)
Date of disclosure of the study information 2012/01/10
Last modified on 2012/07/10

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Basic information
Public title Efficacy and Adherence of Xalacom Combination Therapy in Glaucoma Patients Switching from a Multi-Drug Therapy (PG and beta blocker medication)
Acronym Efficacy and Adherence of Xalacom switching from a Multi-Drug Therapy
Scientific Title Efficacy and Adherence of Xalacom Combination Therapy in Glaucoma Patients Switching from a Multi-Drug Therapy (PG and beta blocker medication)
Scientific Title:Acronym Efficacy and Adherence of Xalacom switching from a Multi-Drug Therapy
Region
Japan

Condition
Condition Glaucoma, ocular hypertension
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the intra ocular pressure, adherence and safety of xalacom after switching from PG analog and a beta blocker concomitant therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Intra ocular pressure of 12Weeks after switching from concomitant therapy
Key secondary outcomes Change rate of intraocular pressure, adherence, safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 12 Weeks administration of Xalacom to the patients who are treated with concomitant application of two or more anti-glaucoma drugs including a PG analogs and a beta blocker over four weeks
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients of glaucoma or ocular hypertension treated with applying a PG analogs and a beta blocker concomitantly
1) Patients who were fully informed and gave their written informed consent to this study
2) IOP in a range of 12 to 21 mmHg
3) visual acuity is over 0.7
4) A doctor decides to switch from such drugs to Xalacom combination eye drops
Key exclusion criteria 1) Patients in whom the studied drug is "Contraindication"
2) Patients in whom the studied drug is "Careful Administration"
3) Patients with corneal abnormalities that would hinder the measurement of IOP using Goldmann applanation tonometry
4) Patients whose pupils could dilate so insufficiently that it is impossible to observe optic papillae
5) Patients with a history of a laser treatment
6) Patients with uveititis, an eye injury, an infectious eye disease or an inflammatory eye disease as an accompanying disease
7) Patients with a history of narrow angle that may be closed, or acute angle closure
8) Patients with a retinal disease that might affect the visual field of either or both eyes, as an accompanying disease
9) Patients with a history of an infectious disease within four weeks of participation in this study
10) Patients who had been using any drug that might have a systemic effect that affects intraocular pressure
11) Patients assessed as unsuitable for participation in the study by the investigator and/or subinvestigators
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Shoji
Organization Kitasato University, School of Allied Health Sciences
Division name Department of Rehabilitation, Orthoptics and Visual Science
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University Hospital
Division name Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email nshoji@ahs.kitasato-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Kitasato University Hospital
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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 10 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 01 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2012 Year 06 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
2012 Year 01 Month 10 Day
Last modified on
2012 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008303

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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