UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011621
Receipt number R000013591
Scientific Title Investigation of IOP reduction efficacy of Travoprost Ophthalmic Solution in patients with normal tension glaucoma
Date of disclosure of the study information 2013/09/02
Last modified on 2014/09/03 18:10:16

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Basic information

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

Condition

normal tension glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Alcon Japan Ltd

Institute

Department

Personal name



Funding Source

Organization

Alcon Japan 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

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)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 02 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 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

Other related information

prospective observational study


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name