UMIN-CTR Clinical Trial

Basic information
Public title	bimatoprost and travoprost/timolol fixed combination in glaucoma
Acronym	bimatoprost and travoprost/timolol fixed combination in glaucoma
Scientific Title	bimatoprost and travoprost/timolol fixed combination in glaucoma
Scientific Title:Acronym	bimatoprost and travoprost/timolol fixed combination in glaucoma
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the intraocular pressure lowering effects of bimatoprost and travoprost/timolol fixed combination in eyes with open-angle glaucoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	efficacy and safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	bimatostost
Interventions/Control_2	travoprost/timolol fixed combination
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	primary open-angle glaucoma or normal-tension glaucoma
Key exclusion criteria	Patients with any secondary factors that might induce glaucoma such as uveitis, and lens exfoliation in even one eye were excluded. Also, patients were excluded if they had any intraocular surgery including laser therapy or had any corneal condition preventing reliable Goldmann applanation tonometry such as pterygium.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Sawada
Organization	Gifu University Graduate School of Medicine
Division name	Ophthalmology
Zip code	501-1194
Address	1-1 Yanagido, Gifu-shi, Japan
TEL	058-230-6000
Email	sawadaa-gif@umin.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Sawada
Organization	Gifu University Graduate School of Medicine
Division name	Ophthalmology
Zip code	501-1194
Address	1-1 yanagido
TEL	058-230-6000
Homepage URL
Email	sawadaa-gif@umin.ac.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gifu University Graduate School of Medicine
Address	1-1 Yanagido, Gifu-shi, Japan
Tel	058-230-6059
Email	rinri@gifu-u.ac.jp

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	2013 Year 02 Month 14 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	Enrolling by invitation
Date of protocol fixation	2011 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2013 Year 04 Month 01 Day
Date of closure to data entry	2013 Year 04 Month 01 Day
Date trial data considered complete	2013 Year 04 Month 01 Day
Date analysis concluded	2013 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2012 Year 02 Month 06 Day
Last modified on	2021 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008528