UMIN-CTR Clinical Trial

Public title

Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.

Acronym

Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.

Scientific Title

Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.

Scientific Title:Acronym

Examination of ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary open angle Glaucoma.

Region

Japan

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate ocular blood flow and reduction of intraocular pressure, comparing Tafuluprost and Tafuruprost Bunazosin with primary angle Glaucoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Ocular blood flow

Key secondary outcomes

Intraocular pressure

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eye drops of tapuros (once daily) for one month. Then add detantole (twice daily) for next one month.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Both eyes was diagnosed glaucoma and untreatmented more than one month.
2) Subject eye is primary open angle glaucoma atleast.And fellow eye can undergo the treatment during test period
3) Outpatients or inpatients.
4) Patients who agreed and signed to the participation in this study.
5) Patients who can observed the schedule written in trial implementation protocol.
6) IOP(fellow eye)<=30

Key exclusion criteria

1) Patients who have ocular diseases without glaucoma and mild cataract(diabates retinopathy or morbid myopia or etc)
2) Progressive or severe glaucoma(for example using a Humphery field analyzer,MD <-12dB,0dB detection is in 5degree)
3) Patients with any corneal abnormality or other condition preventing reliable applanation tonometry.
4) Patients with anamnestic hitory of hypersensitivity to prostagrandin analogs and benzalkonium chloride.
5) Patients with active external ocular diseases,ocular inflammation or infection.
6) Patients with history of reflactive surgery.
7) Patients with history of internal ocular surgery within 6month before the study (cataract surgery,SLT,trabecrctomy,trabecrotomy etc).
8) Smoker
9) Patients who are unable to undergo ocular blood flow test.
10) Pregnant,lactating women ,the women who desired of the pregnancy during the test period.
11) Patients who are going to use prohibited drugs during test period.
12) Doctor judged to be inelible to the study.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Kazuhisa Sugiyama

Organization

Kanazawa University

Division name

Department of Ophthalmology

Zip code

Address

13-1 Takara-machi, Kanazawa, Ishikawa

TEL

076-265-2403

Email

ksugi@med.kanazawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazuhisa Sugiyama

Organization

Kanazawa University

Division name

Department of Ophthalmology

Zip code

Address

13-1 Takara-machi, Kanazawa, Ishikawa

TEL

076-265-2403

Homepage URL

Email

ksugi@med.kanazawa-u.ac.jp

Institute

Department of Ophthalmology, Kanazawa University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

金沢大学附属病院（石川県）

Date of disclosure of the study information

2013

Year

07

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Instillation of tafluprost significantly reduced intraocular pressure, but there was no change in microcirculation of optic disc.

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

01

Month

15

Day

Date of IRB

Anticipated trial start date

2009

Year

02

Month

19

Day

Last follow-up date

2009

Year

11

Month

04

Day

Date of closure to data entry

2009

Year

11

Month

04

Day

Date trial data considered complete

2009

Year

11

Month

04

Day

Date analysis concluded

2009

Year

11

Month

08

Day

Other related information

Registered date

2013

Year

07

Month

30

Day

Last modified on

2014

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013204