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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035908
Receipt No. R000040886
Scientific Title A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Date of disclosure of the study information 2019/02/18
Last modified on 2019/05/14

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Basic information
Public title A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Acronym A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Scientific Title A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Scientific Title:Acronym A randomized, placebo-controlled, double-blind, parallel-group trial of observations of subjective and objective symptoms of eye fatigue and testing for improvement with the ingestion of bilberry extract
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effect of the test food on eye function in healthy Japanese men and women aged 25 years or older and 40 years or younger who have continued to consume the test food for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual fatigue
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4-week intake of the containing bilberry extract food of 1 capsule a day
Interventions/Control_2 4-week intake of the placebo food of 1 capsule a day
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
25 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy Japanese men and women aged 25 to 40 years
2) People who feel tired of their eyes
3) Persons who routinely perform PC (PC) tasks or driving a car
4) Persons who have not undergone LASIK surgery (myopia correction surgery)
5) Subjects with uncorrected visual acuity of 0.2 or better at both eyes.
6) Persons who can be contacted by personal computers or smartphones
7) Persons with a BMI of 25 kg/m2 or less
8) People who can play games with smartphones for about 30 minutes
9) Subjects who are able to discontinue eye drops during the study period"
Key exclusion criteria 1) Patients who are currently receiving any medications or outpatient
2) Subjects currently undergoing exercise or diet therapy under the supervision of a physician
3) Persons with a history or current disease or complication of liver disease or serious diseases of renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic origin.
4) Persons who have been treated or had a history of chronic disease (arrhythmia, liver, kidney, cerebrovascular disease, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases)
5) Persons who have had surgery of the digestive tract (appendicitis is allowed)
6) People who have pollinosis
7) Patients with ocular diseases other than refractive errors (hyperopia, myopia, astigmatism)
8) Persons with a history of drug allergy or food allergy
9) Those who wish to do so during pregnancy, lactation, or the study period.
10) Those who have received blood donations or vaccinations within the previous three months or who are scheduled to do so during the study period.
11) Persons who regularly consume health foods, supplements, and medicines that may affect eye function.
12) Persons who are in hospital due to mental disorders (depression etc.), sleeping disorders, etc., or who have a past medical history in the past.
13) Persons who are under treatment or have a history of alcohol dependence, drug dependence or drug abuser.
14) Person who is in shift work such as night work
15) Extremely irregular lifestyle, such as eating and sleeping
16) Current smokers
17) Subjects who have participated in other clinical trials or are currently participating in other clinical trials within the past 3 months of the date of informed consent.
18) Persons who have difficulty complying with the records of various surveys
19) Other persons for whom the principal investigator judges it inappropriate for the study.
"
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Kosehira
Middle name
Last name Marie
Organization Omnica Co.,Ltd
Division name Research and development Dept.
Zip code 112-0002
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9815
Email kosehira@omnica.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Omnica Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committees of Nihonbashi Egawa Clinic
Address 2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel 03-5204-0311
Email jim@medipharma.co.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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 18 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 37
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
2019 Year 01 Month 11 Day
Date of IRB
2019 Year 01 Month 15 Day
Anticipated trial start date
2019 Year 02 Month 14 Day
Last follow-up date
2019 Year 04 Month 06 Day
Date of closure to data entry
2019 Year 04 Month 08 Day
Date trial data considered complete
2019 Year 04 Month 28 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 02 Month 18 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040886

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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