UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015823
Receipt number R000018087
Scientific Title Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution
Date of disclosure of the study information 2014/12/05
Last modified on 2016/06/02 09:10:57

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Basic information

Public title

Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution

Acronym

Switching from latanoprost or travoprost to tafruprost and timolol fixed ophthalmic solution

Scientific Title

Switching from latanoprost or travoprost ophthalmolic solution to tafruprost and timolol fixed ophthalmic solution

Scientific Title:Acronym

Switching from latanoprost or travoprost to tafruprost and timolol fixed ophthalmic solution

Region

Japan


Condition

Condition

Primary open angle glaucoma and ocular hypertension

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of tafloprost and timolol fixed combination by switching latanoprost or travoprost monotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reduction of intraocular pressure
Topical and systemic adverse effects

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 latanoprost or travoprost monotherapy to tafluprost/timolol fixed combination

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

Primary open angle glaucoma
Ocular hypertension

Key exclusion criteria

Severe respiratory diseases
Severe systemic diseases
Allegic reaction against contents of the experimental compounds

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Kashiwagi

Organization

University of Yamanashi

Division name

Ophthalmology

Zip code


Address

1110 Shimokato Chuo Yamanashi

TEL

055-273-1111

Email

kenjik@yamanashi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Kashiwagi

Organization

University of Yamanashi

Division name

Ophthalmology

Zip code


Address

1110 Shimokato Chuo Yamanashi

TEL

055-273-1111

Homepage URL


Email

kenjik@yamanashi.ac.jp


Sponsor or person

Institute

University of Yamanashi

Institute

Department

Personal name



Funding Source

Organization

Santen Pharmaceitical 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



Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 05 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

Main results already published

Date of protocol fixation

2014 Year 11 Month 20 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2016 Year 02 Month 29 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 02 Day

Last modified on

2016 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name