Unique ID issued by UMIN | UMIN000014810 |
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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 |
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
Assessment of AIPHAGAN Addition in PG treated NTG (AAA-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
Assessment of AIPHAGAN Addition in PG treated NTG (AAA-study)
Japan |
Normal Tension Glaucoma
Ophthalmology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Mean changes from baseline intraocular pressure at week 12
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Active
NO
NO
Institution is considered as a block.
YES
No need to know
2
Treatment
Medicine |
0.1%Brimonidine Tartrate, b.i.d. for 12weeks
0.5%Timolol Maleate, b.i.d. for 12weeks
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients have been treated with PGAs for at least 90 days
2) Patients with intraocular pressure of 16.0mmHg or lower
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.
144
1st name | |
Middle name | |
Last name | Keiji Yoshikawa |
Yoshikawa Eye Clinic
Director
1-3-1 Nakamachi Machida-city Tokyo
042-739-0781
keiyomd@ark.ocn.ne.jp
1st name | |
Middle name | |
Last name | Shiro Mizoue |
Ehime University Graduate School of Medicine
Department of Ophthalmology
Shitsukawa Toon-city, Ehime, Japan.
089-960-5361
mizoue@m.ehime-u.ac.jp
AAA study group
SENJU Pharmaceutical Co.,ltd.
Profit organization
Tokyo Teishin Hospital
Kinki University
NO
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)
2014 | Year | 08 | Month | 10 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 17 | Day |
2014 | Year | 09 | Month | 01 | Day |
2014 | Year | 08 | Month | 10 | Day |
2016 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017219
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