UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033200
Receipt number R000037855
Scientific Title Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.
Date of disclosure of the study information 2018/10/05
Last modified on 2019/07/04 13:54:00

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Basic information

Public title

Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.

Acronym

Effects of a test food on antioxidative action in blood.

Scientific Title

Effect of a test food on blood antioxidative action of primary open-angle glaucoma patients.

Scientific Title:Acronym

Effects of a test food on antioxidative action in blood.

Region

Japan


Condition

Condition

Primary open-Angle Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of a test food on blood antioxidative action of primary open-angle glaucoma patients. And effect on intraocular pressure are also investigated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Antioxidative stress marker in blood, intraocular pressure

Key secondary outcomes

Adverse Effects/Side Effects


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Oral intake of test food (1 pill in a day, 4 weeks)

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Males and Females aged 20 years over and aged under 70 years old
[2] Individuals whose written informed consent has been obtained
[3]Individuals whose both eye were prevent from glaucoma progression by treating with 1 to 3 medication, and individuals who do not need the ophthalmic surgery including glaucoma operation
[4] Individuals who want to take the test food
[5] Individuals whose intraocular pressure was higher than 15 mmHg with Goldmann applanation tonometer in at least one eye.
[6] Individuals who can measure the intraocular pressure with ICare HOME tonoometer
[7] Individuals whose measuring times of intraocular pressure with ICare HOME tonometer in pre-dosing period were greater than (days of pre-dosing period x2) times

Key exclusion criteria

[1] Individuals with serious systematic disease
[2] individuals with ocular disease which may leads the blindness except glaucoma or mild cataract
[3] Individuals with hepatic or renal failure, cardiac failure, renal failure which having influence to supplement evaluation.
[4] individuals with cigarettes smoker
[5] Individuals who continuously used a antioxidative supplement or have plan to use said supplements during the study period
[6] Individuals who are likely to change the lifestyle (long journey, change in Eating habits etc.).
[7] Individuals who is pregnant, lactating, or may possibly be pregnant.
[8] Individuals who entry into another clinical trial, or has a history of the entry into other clinical trials within 3 months
[9] Individuals with allergy to test food or who may possibly be allergy to test food.
[10] Individuals who are inappropriate case judged by investigator or subinvestigators.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Tanito

Organization

Shimane University

Division name

Ophthalmology

Zip code

693-8501

Address

89-1, Shiochi-cho, Izumo, Shimane Prefecture

TEL

0853-20-2284

Email

mtanito@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Yasutaka
Middle name
Last name Takagi

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs Group

Zip code

530-8552

Address

4-20, Ofukacho, Kita-ku, Osaka 530-8552, Japan

TEL

+81-6-4802-9337

Homepage URL


Email

clinical@santen.co.jp


Sponsor or person

Institute

Shimane University

Institute

Department

Personal name



Funding Source

Organization

Santen Pharmaceutical Co., 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

Shimane University

Address

89-1, Shiochi-cho, Izumo, Shimane Prefecture

Tel

0853-20-2259

Email

kenkyu@med.shimane-u.ac.jp


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

松江赤十字病院(島根県)/Matsue Red Cross Hospital (Shimane Pref.)
島根大学(島根県)/ Shimane University (Shimane pref.)


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 05 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

18

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

2018 Year 02 Month 26 Day

Date of IRB

2018 Year 03 Month 16 Day

Anticipated trial start date

2018 Year 07 Month 06 Day

Last follow-up date

2019 Year 01 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 29 Day

Last modified on

2019 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037855


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name