UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002757
Receipt number R000003351
Scientific Title Clinical effects of once daily-type beta-blockers in glaucoma patients
Date of disclosure of the study information 2009/11/13
Last modified on 2014/05/12 13:12:21

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Basic information

Public title

Clinical effects of once daily-type beta-blockers in glaucoma patients

Acronym

Clinical effects of once daily-type beta-blockers in glaucoma patients

Scientific Title

Clinical effects of once daily-type beta-blockers in glaucoma patients

Scientific Title:Acronym

Clinical effects of once daily-type beta-blockers in glaucoma patients

Region

Japan


Condition

Condition

glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the IOP reducing effect and prevalence of side effects between topical treatments with Rysmon TG and Mikelan LA.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual acuity, intraocular pressure, frequency of side effects

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rysmon TG-Mikelan LA

Interventions/Control_2

Mikelan LA-Rysmon TG

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

glaucoma

Key exclusion criteria

None

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Tanito

Organization

Shimane University Faculty of Medicine

Division name

Ophthalmology

Zip code


Address

Enya 89-1, Izumo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Shimane University Faculty of Medicine

Division name

Department of Ophthalmology

Zip code


Address


TEL


Homepage URL


Email

tanito-oph@umin.ac.jp


Sponsor or person

Institute

Departmet of Ophthalmology, Shimane University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2009 Year 11 Month 13 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

Completed

Date of protocol fixation

2009 Year 11 Month 12 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 04 Month 30 Day

Date analysis concluded

2014 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2009 Year 11 Month 12 Day

Last modified on

2014 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name