UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023883
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public 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%.

Acronym

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%.

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%.

Scientific Title:Acronym

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%.

Region

Japan


Condition

Condition

primary open angle glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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%.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mean 24-hr IOP

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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

Interventions/Control_2


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

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

Key exclusion criteria

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)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayo Hashimoto

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs Group, Development Management Department, Japan Business

Zip code


Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9337

Email

clinical@santen.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naomi Otsuka

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs Group, Development Management Department, Japan Business

Zip code


Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9603

Homepage URL


Email

clinical@santen.co.jp


Sponsor or person

Institute

Santen Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Santen Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

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)


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


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

2016 Year 08 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 10 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

2016 Year 09 Month 01 Day

Last modified on

2018 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name