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Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000016052
Date of registration:	29/12/2014
Prospective Registration:	No
Primary sponsor:	Inouye Eye Hospital
Public title:	Efficacy of IOP reduction and safety of Tapcom combination ophthalmic solution switched from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution.
Scientific title:	Efficacy of IOP reduction and safety of Tapcom combination ophthalmic solution switched from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution. - Efficacy of IOP reduction and safety of Tapcom combination ophthalmic solution switched from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution.
Date of first enrolment:	2014/12/12
Target sample size:	30
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018656
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	1.Kenji Inoue 2.Masayo Hashimoto
Address:	1.4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan 2. 4-20, Ofukacho, Kita-ku, Osaka Japan
Telephone:	1.03-3295-0911
Email:	1.study@inouye-eye.or.jp
Affiliation:	1.Inouye Eye Hospital 2.Santen Pharmaceutical Co., Ltd. 1.Medical office 2.Japan Medical Affairs Group, Development Management Department, Japan Business

Name:	Kenji Inoue
Address:	4-3 Kanda Surugadai, Chiyoda-Tokyo, Japan Japan
Telephone:	03-3295-0911
Email:	study@inouye-eye.or.jp
Affiliation:	Inouye Eye Hospital Medical office

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: some corneal abnormality or other diseases which may interfere with accurate IOP measurement history of glaucoma surgery contraindicated to Beta blockers

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

primary open angle glaucoma or ocular hypertension

Intervention(s)

Switching from Tapros 0.0015% and Timoptol XE 0.5% ophthalmic solution to Tapcom combination ophthalmic solution

Primary Outcome(s)

IOP reduction Adverse event

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Santen Pharmaceutical Co., Ltd.

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:	https://doi.org/10.2147/OPTH.S150595

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