UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011691
Receipt number R000012003
Scientific Title Efficacy of brimonidine for transient IOP rise after cataract surgery
Date of disclosure of the study information 2013/09/15
Last modified on 2015/03/11 13:14:11

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Basic information

Public title

Efficacy of brimonidine for transient IOP rise after cataract surgery

Acronym

Efficacy of brimonidine for transient IOP rise after cataract surgery

Scientific Title

Efficacy of brimonidine for transient IOP rise after cataract surgery

Scientific Title:Acronym

Efficacy of brimonidine for transient IOP rise after cataract surgery

Region

Japan


Condition

Condition

cataract

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Brimonidine on inflammation and IOP of post-operative patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IOP

Key secondary outcomes

flare


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

Brimonidine

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. Patients who are scheduled for cataract surgery.
2. Aged 20 years or more.
3. Patients who are able to visit Hiroshima University Hospital through study period.
4. Have provided a written informed consent.

Key exclusion criteria

1.Patients with glaucoma
2.Patients with a history of intraocular surgery past 6 momth.
3. Patients who have difficulty for IOP measurement with applanation tonometer.
4.Patients who with a history of uveitis, ocular infection, and severe dry eye.
5.Patients who are treated with steroids or any NSAIDs.
6. Patients who have cardiovascular disease, cerebrovascular disease, and hypotension.
7.patients with diabetes mellitus.
8. Patients who the investigator consider ineligible for enrolment.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Kiuchi

Organization

Hiroshima University

Division name

Ophthalmology

Zip code


Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5247

Email

ykiuchi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Ideguchi

Organization

Hiroshima University

Division name

Ophthalmology

Zip code


Address

1-2-3, Kasumi, Minami-ku, Hiroshima

TEL

082-257-5247

Homepage URL


Email

ideguchi@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima Uiversity

Institute

Department

Personal name



Funding Source

Organization

Hiroshima Uiversity

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

2013 Year 09 Month 15 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

2013 Year 09 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 15 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

2013 Year 09 Month 09 Day

Last modified on

2015 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name