UMIN-CTR Clinical Trial

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Recruitment status Completed
Unique ID issued by UMIN UMIN000014810
Receipt No. R000017219
Scientific Title 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
Date of disclosure of the study information 2014/08/10
Last modified on 2016/12/15

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Basic information
Public title 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
Acronym Assessment of AIPHAGAN Addition in PG treated NTG (AAA-study)
Scientific Title 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
Scientific Title:Acronym 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

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 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

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) 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
Last name of lead principal investigator
1st name
Middle name
Last name Keiji Yoshikawa
Organization Yoshikawa Eye Clinic
Division name Director
Zip code
Address 1-3-1 Nakamachi Machida-city Tokyo
TEL 042-739-0781
Email keiyomd@ark.ocn.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shiro Mizoue
Organization Ehime University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
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

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 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)

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 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

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 Completed
Date of protocol fixation
2014 Year 07 Month 17 Day
Date of IRB
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

Other
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


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