UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004224
Receipt number R000005078
Scientific Title Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%
Date of disclosure of the study information 2010/09/17
Last modified on 2011/03/10 21:09:41

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Basic information

Public title

Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%

Acronym

Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%

Scientific Title

Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%

Scientific Title:Acronym

Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison study for ocular hypotensive effect of switching from Travoprost 0.004% and Timolol maleate(Timoptol®-XE ophthalmic Solution 0.5%) ,Travoprost 0.004% and long-acting 2% Carteolol to a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5%

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

IOP reduction

Key secondary outcomes

Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Investigation for efficacy,safety a conbined opthalmic solution Travoprost 0.004%/Timolol 0.5% once daily for a month into one of a subject

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

1 At Measurement for IOP base line, patient who has to fill over or equal 20 years-old 2 Out of consideration for gender, inpatient and outpatient 3.Patient, who has been managed Travoprost 0.004% and Timolol 0.5% or long-acting 2% Carteolol over a month till measurement of IOP baseline. 4.Patient, who has been accepted by Dr as candidate of switching to combination drug .

Key exclusion criteria

1Patient, who has been managed due to chronic or replace uvetis, sceritis and herpes cornea. 2.Patient, who has been managed by traumatic diseases,ocular surgery,laser operation within 3 months. 3.Patinet, who is not available to measure by Aplanation tonomater. 4.Patinet, who has irritation for PG eye solution, related PG eye solution and Benzalkonium chloride(BAC). 5.Patient, who is severe Alzheimer. 6.Patinet, who has been managed by oral CAI or steroid eye solution. 7.Patinet, who has been applied other IOP reductive drug.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiichi Nomura

Organization

Yokohama City University Hospital

Division name

Department of Ophthalmology

Zip code


Address

3-9 Fukuura Kanazawa-Word Yokohama city Kanagawa,Japan

TEL

045-787-2800

Email



Public contact

Name of contact person

1st name
Middle name
Last name Eiichi Nomura

Organization

Yokohama City University Hospital

Division name

Department of Ophthalmology

Zip code


Address

3-11 Fukuura Kanazawa-Word Yokohama city Kanagawa,Japan

TEL

045-787-2800

Homepage URL


Email



Sponsor or person

Institute

Department of Ophthalmology Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Myself

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

横浜市立大学附属病院(神奈川県)/金沢病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 17 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

Enrolling by invitation

Date of protocol fixation

2010 Year 09 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2013 Year 09 Month 01 Day

Date of closure to data entry

2013 Year 09 Month 01 Day

Date trial data considered complete

2013 Year 12 Month 01 Day

Date analysis concluded

2013 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 16 Day

Last modified on

2011 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name