UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005426 |
|---|---|
| Receipt number | R000006441 |
| Scientific Title | Crossover comparative study of latanoprost/timolol fixed combination with combined therapy comprised of latanoprost and timolol |
| Date of disclosure of the study information | 2011/04/22 |
| Last modified on | 2018/10/19 08:45:16 |
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Basic information
Public title
Crossover comparative study of latanoprost/timolol fixed combination with combined therapy comprised of latanoprost and timolol
Acronym
Xalacom crossover study
Scientific Title
Crossover comparative study of latanoprost/timolol fixed combination with combined therapy comprised of latanoprost and timolol
Scientific Title:Acronym
Xalacom crossover study
Region
| Japan |
Condition
Condition
glaucoma, ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of intraocular pressure (IOP)between latanoprost/timolol fixed combination and combined therapy comprised of latanoprost and timolol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IOP after 8-week treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
combined therapy: latanoprost and timolol 0.5% for 8 weeks
Interventions/Control_2
latanoprost/timolol fixed combination (Xalacom) for 8 weeks
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
Open-angle glaucoma or ocular hypertension
IOP between 12 and 20 mmHg with latanoprost and timolol 0.5%; Concomitant use of other anti-glaucoma drugs permitted
Key exclusion criteria
Contraindication for latanoprost or timolol
MD worse than or equal to -25dB (HFA 30-2)
BCVA less than 0.5
Refractive error greater than or equal to +9.0D, or less than -9.0D
Goldmann applanation tomometry or disc evaluation difficult or impossible
History of intraocular surgery or laser
Other ocular diseases which may affect the results
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Yamamoto |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1 Yanagido, Gifu-shi, Japan
TEL
058-230-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
058-230-6000
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Gifu University Graduate School 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
岐阜大学病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 22 | 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
| 2011 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 12 | 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
| 2011 | Year | 04 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006441
