UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007042 |
|---|---|
| Receipt number | 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 13:23:53 |
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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
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
nshoji@ahs.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kitasato University Hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008303
