UMIN-CTR Clinical Trial

Public title

Examination on an influence of a test food product on oxidative stress in glaucoma patients

Acronym

Examination on an influence of a test food product on oxidative stress in glaucoma patients

Scientific Title

Examination on an influence of a test food product on oxidative stress in glaucoma patients

Scientific Title:Acronym

Examination on an influence of a test food product on oxidative stress in glaucoma patients

Region

Japan

Condition

Normal tension glaucoma patients

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine an influence of a test food product on oxidative stress in normal tension glaucoma patients aged 40 and over and assigning them to take the test food product for four weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

8-OHdG

Key secondary outcomes

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

Prevention

Type of intervention

Food

Interventions/Control_1

Four-week intake of the test food product

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

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Males and females with Japanese nationality aged 40 and over
2) Diagnosed with normal tension glaucoma
3) Persons who can bring their glaucoma medication on study days
4) Low in biological antioxidant potential (BAP) and high in oxidative stress (8-OHdG) in urine

Key exclusion criteria

"1) Presence of severe ophthalmic disorder and regular visit to an ophthalmic clinic
2) High myopia
3) Within three months after eye surgery
4) Previous history of the LASIK procedure
5) Presence of disorder with a possible influence on study results (cancer, high-blood pressure, diabetes, amblyopia, autoimmune disorder, dysthyroidism, etc.)
6) Intake of a food product (antioxidant supplements other than vitamin C, etc.) with a possible influence on the study results at a frequency of once a week or more within the last month, or desired to take the food product at the frequency of once a week or more
7) Previous history of drug allergy or food allergy, possible onset of allergy by the study
8) Currently in treatment with medication that regulates blood pressure or blood flow
9) Presence of disorder that requires constant medication, or previous history of severe disorder that required treatment with medication
10) Regular intake of another supplement or non-prescription drug (including ophthalmic drops for purposes other than glaucoma treatment of glaucoma)
11) Persons whose results of clinical and physical examination prior to intake of the test food product significantly deviate from reference ranges
12) Current participation in another clinical study or participation in another clinical study within the last month since acquisition of the consent
13) Pregnant or desired to become pregnant and nurse during the study period
14) Determined to be unsuitable as subjects from results of the lifestyle survey
15) Determined by the investigator to be unsuitable for enrollment in this study
"

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	ochitani daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

OekkusuBldg.10F,5-31-19 ShibaMinato-ku, Tokyo 108-0014 Japan

TEL

03-3431-1260

Email

ochitani@huma-c.co.jp

Name of contact person

1st name
Middle name
Last name	ochitani daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

OekkusuBldg.10F,5-31-19 ShibaMinato-ku, Tokyo 108-0014 Japan

TEL

03-3431-1260

Homepage URL

Email

ochitani@huma-c.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

Wakomoto Pharmaceutical Co.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

Date of disclosure of the study information

2017

Year

08

Month

07

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

2017

Year

07

Month

14

Day

Date of IRB

Anticipated trial start date

2017

Year

08

Month

02

Day

Last follow-up date

2017

Year

10

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

04

Day

Last modified on

2018

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032664