UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014810 |
|---|---|
| Receipt number | 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 20:00:12 |
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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
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
| 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
keiyomd@ark.ocn.ne.jp
Public contact
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
mizoue@m.ehime-u.ac.jp
Sponsor or person
Institute
AAA study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017219
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| Registered date | File name |
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