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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005426
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Ophthalmology, Gifu University Graduate School 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006441

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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