UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter, randomized, investigator-masked study comparing brimonidine tartrate 0.1% and timolol maleate 0.5% as adjunctive therapies to prostaglandin analogs in normal tension glaucoma
Title of the study (Brief title)	Assessment of AIPHAGAN Addition in PG treated NTG (AAA-study)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of brimonidine tartrate 0.1% or timolol maleate 0.5% in normal tension glaucoma patients who are treated with prostaglandin analogs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mean changes from baseline intraocular pressure at week 12
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.1%Brimonidine Tartrate, b.i.d. for 12weeks
Interventions/Control_2	0.5%Timolol Maleate, b.i.d. for 12weeks
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	1) Patients have been treated with PGAs for at least 90 days 2) Patients with intraocular pressure of 16.0mmHg or lower
Key exclusion criteria	1) Any active ocular disease 2) Highly visual field loss(e.g. the mean deviation<-20dB) 3) Corneal thickness is less than 450um, or more than 600um 4) History of trabeclotomy or trabeculectomy 5) Medical history of allergic or severe adverse event to brimonidine or timolol.
Target sample size	144

Research contact person
Name of lead principal investigator	Keiji Yoshikawa
Organization	Yoshikawa Eye Clinic
Division name	Director
Address	1-3-1 Nakamachi Machida-city Tokyo
TEL	042-739-0781
Email	keiyomd@ark.ocn.ne.jp

Public contact
Name of contact person	Shiro Mizoue
Organization	Ehime University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	Shitsukawa Toon-city, Ehime, Japan.
TEL	089-960-5361
Homepage URL
Email	mizoue@m.ehime-u.ac.jp

Sponsor
Institute	AAA study group
Institute
Department

Funding Source
Organization	SENJU Pharmaceutical Co.,ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Teishin Hospital Kinki University
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	新田眼科（群馬県）、二本松眼科病院（東京都）、上野眼科医院（東京都）、吉川眼科クリニック（東京都）、木戸眼科（新潟県）、福井県済生会病院（福井県）、山林眼科（愛知県）、南松山病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 17 Day
Anticipated trial start date	2014 Year 09 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 10 Day
Last modified on	2016 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017219