UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparable study between bimatoprost and latanoprost/timolo fixed combination in primary open angle glaucoma patients
Title of the study (Brief title)	Comparable study between bimatoprost and latanoprost/timolo fixed combination in primary open angle glaucoma patients
Region	Japan

Condition
Condition	Primary open angle glaucoma patients
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety between bimatoprost and latanoprost/timolol fixed combination therapy in POAG patients with latanoprost monotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intraocular pressure, ocular and general side effects
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	bimatoprost administration
Interventions/Control_2	latanoprost/timolol fixed combination administration
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) POAG patients 2) Under latanoprost monotherapy more than 4 weeks 3) Need to decrease IOP 4) who have judged to have a good compliance
Key exclusion criteria	1) past history of side effects in beta blocker usage 2) any patients who have any active ocular disease except for glaucoma 3) who have any active retinal diseases 4) past history of reflactive surgery, filtering surgery, and trabeculotomy 5) any intraocular surgeries including laser therapy within 6 months 6) need contact lens usage during the study periods 7) who have the possibility to use medical therapy which influences IOP 8) who have corneal disorders which disturb the GAT measurement 9) who have decided to be inappropriate for this study by a physician in charge
Target sample size	80

Research contact person
Name of lead principal investigator	Kazuhiko Mori
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Address	Kawaramachi Hitokouji, Kamigyoku, Kyoto 602-0841, JAPAN
TEL	075-251-5578
Email	kmori@koto.kpu-m.ac.jp

Public contact
Name of contact person	Kazuhiko Mori, Morio Ueno, Yoko Ikeda
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Address	Kawaramachi Hitokouji, Kamigyoku, Kyoto 602-0841, JAPAN
TEL	075-151-5575
Homepage URL
Email	kmori@koto.kpu-m.ac.jp

Sponsor
Institute	Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2010 Year 12 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 11 Month 20 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 21 Day
Last modified on	2016 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005487