Unique ID issued by UMIN | UMIN000023883 |
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Receipt number | R000027491 |
Scientific Title | IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%. |
Date of disclosure of the study information | 2016/09/08 |
Last modified on | 2018/03/16 11:13:03 |
IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%.
IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%.
IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%.
IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution switched from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5%.
Japan |
primary open angle glaucoma
Ophthalmology |
Others
NO
To investigate IOP-lowering effect lasting for 24 hours of Tapcom combination ophthalmic solution in primary open angle glaucoma patients who switch treatment from Tapros ophthalmic solution 0.015% and Timoptol XE ophthalmic solution 0.5%.
Safety,Efficacy
Mean 24-hr IOP
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Switching from Tapros ophthalmic solution 0.0015% and Timoptol XE ophthalmic solution 0.5% to Tapcom combination ophthalmic solution.
20 | years-old | <= |
Not applicable |
Male and Female
Patients with unilateral or bilateral primary open angle glaucoma
Patients who can visit the hospital according to the observation/test schedule determined in the study protocol
Patients with some corneal abnormality or other diseases which may interfere with accurate IOP measurement using Goldmann applanation tonometer
Patients with a history of corneal refractive surgery
Patients with active extraocular disease, inflammation or infection in the eye(s) or eyelid(s)
Patients with allergy to the ingredients used in the present study
Pregnant, lactating women or women who may be pregnant, and women who wish to be pregnant or can not conduct appropriate contraception during the study period
Patients who are contraindicated to beta blockers (those who with bronchial asthma or insufficiently controlled heart failure)
20
1st name | |
Middle name | |
Last name | Masayo Hashimoto |
Santen Pharmaceutical Co., Ltd.
Japan Medical Affairs Group, Development Management Department, Japan Business
4-20, Ofukacho, Kita-ku, Osaka
06-4802-9337
clinical@santen.co.jp
1st name | |
Middle name | |
Last name | Naomi Otsuka |
Santen Pharmaceutical Co., Ltd.
Japan Medical Affairs Group, Development Management Department, Japan Business
4-20, Ofukacho, Kita-ku, Osaka
06-4802-9603
clinical@santen.co.jp
Santen Pharmaceutical Co., Ltd.
Santen Pharmaceutical Co., Ltd.
Profit organization
NO
医療法人社団 信濃会 信濃坂クリニック(東京都)/ Medical Corporation Shinanokai SHINANOZAKA CLINIC (Tokyo)
2016 | Year | 09 | Month | 08 | Day |
Published
Completed
2016 | Year | 08 | Month | 05 | Day |
2016 | Year | 08 | Month | 10 | Day |
2016 | Year | 09 | Month | 01 | Day |
2018 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027491
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