UMIN-CTR Clinical Trial

Public title

Investigation of IOP reduction efficacy of Travoprost Ophthalmic Solution
in patients with normal tension glaucoma

Acronym

Investigation of IOP reduction efficacy of Travoprost Ophthalmic Solution
in patients with normal tension glaucoma

Scientific Title

Investigation of IOP reduction efficacy of Travoprost Ophthalmic Solution
in patients with normal tension glaucoma

Scientific Title:Acronym

Investigation of IOP reduction efficacy of Travoprost Ophthalmic Solution
in patients with normal tension glaucoma

Region

Japan

Condition

normal tension glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (benzalkonium chloride (BAC) free) (hereafter referred to as Travatanz) in patients with normal tension glaucoma using Travatanz monotherapy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Efficacy
Main Outcome Measures
IOP change values from baseline pooled at 9 o'clock at 4, 8 and 12 weeks.

Key secondary outcomes

Secondary Outcome Measures
IOP change values and change rates from baseline at 9 o'clock at 4, 8 and 12 weeks, and at 13 o'clock and 17 o'clock at 12 weeks.

Safety
Slit-lamp biomicroscopy, conjunctival hyperemia, SPK, periocular changes, adverse event

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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.Subjects who do not start new IOP lowering ophthalmic solution or are not on current medication and diagnosed as normal tension glaucoma.

2.Subjects who can understand informed consent forms approved by Ethical Review Board and provide consent.

3.Subjects aged 20 or more at the time of consent obtained.

4.Subjects whose IOPs of the included eye at 9 o'clock, 13 o'clock and 17 o'clock at baseline are more than 10 mmHg and 20 mmHg or less.

5.No criteria on sex.

6.No criteria on outpatient/inpatient.

Key exclusion criteria

1.Pregnant women, lactating women or
women who wish pregnancy during the study period.

2.A subject with Angle Grade in Shaffer classification 2 or less
3.Subjects whose glaucoma may be advanced and serious (less than -12 dB in MD).

4.Subjects who have complicated chronic or recurrent uveitis, scleritis or corneal herpes.

5.Subjects who have a history of ocular trauma, intraocular surgery or laser surgery for the included eye.

6.Subjects with ocular-infection and severe ocular complication.

7.Subjects whose BCVA is worse than 0.2.

8.Subjects who are difficult to conduct applanation tonometry for the included eye.

9.Subjects with known hypersensitivity to prostaglandin analogues or any ingredients used in the study.

10.Subjects who must use IOP lowering ophthalmic solutions other than Travatanz or oral carbonic anhydrase inhibitor (Diamox etc.) during the study period.

11.Subject who need any
adrenocorticosteroids during the study period.

12.Subjects who received IOP lowering ophthalmic solution within the past 30 days.

13.Subjects whose doctors judged they are not suitable for the study participation.

Target sample size

34

Name of lead principal investigator

1st name
Middle name
Last name	Shirou Mizoue

Organization

Minami-Matsuyama Hospital

Division name

Ophthalmology

Zip code

Address

1-3-10 Asodamachi Matsuyama City, Ehime 790-0952 japan

TEL

089-941-8255

Email

mizoue@m.ehime-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Yabe

Organization

Bell Medical Solutions Inc

Division name

Clinical Research Group Clinical Research and Development Division

Zip code

Address

Toukyu Bldg.East No,3 2-16-8,Minami-Ikebukuro,Toshimaku,Tokyo 171-0022 JAPAN

TEL

03-5953-9016

Homepage URL

Email

yabe.hiroshi@bell-medical.co.jp

Institute

Alcon Japan Ltd

Institute

Department

Personal name

Organization

Alcon Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

南松山病院（愛媛県）
尾崎眼科（宮崎県）
島根大学（島根県）
岡山大学（岡山県）
永山眼科クリニック（岡山県）
住友別子病院（愛媛県）

Date of disclosure of the study information

2013

Year

09

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

28

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

01

Day

Last follow-up date

2014

Year

08

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

prospective observational study

Registered date

2013

Year

09

Month

02

Day

Last modified on

2014

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013591