UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044905
Receipt number R000051236
Scientific Title Effect of supplement foods on accommodation of eye
Date of disclosure of the study information 2021/07/20
Last modified on 2022/06/07 09:04:54

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Basic information

Public title

Effect of supplement foods on accommodation of eye

Acronym

Effect of supplement foods on accommodation of eye

Scientific Title

Effect of supplement foods on accommodation of eye

Scientific Title:Acronym

Effect of supplement foods on accommodation of eye

Region

Japan


Condition

Condition

N/A (Healthy adults)

Classification by specialty

Ophthalmology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of supplement food on accommodation of eye in healthy Japanese adult volunteers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in accommodation of eye

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

Take supplement food once daily for 12 weeks

Interventions/Control_2

Take placebo once daily for 12 weeks

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

30 years-old <=

Age-upper limit

45 years-old >

Gender

Male and Female

Key inclusion criteria

Both eyes with visual acuity of 0.7 or more (uncorrected or corrected)
Those who are aware of continuous eye fatigue after more than 4 hours VDT operation per day.
Those who are can visited clinic on schedule and can be performed planned examinations and observations.

Key exclusion criteria

Those who have any complication other than refractive error (eyes or whole body).
Those who have a history of ocular surgery or are scheduled during the study period (including refractive corneal surgery and laser therapy).
Those who cannot discontinued drugs for the eye or eyelid during the study period (including OTC drugs).
Those who have changed lens powers of contact lenses or glasses within the past month or are scheduled to be changed during the study period.
Those who have continuous consumption of health foods (including supplements) within the past 3 months or will be consumed during the study period.
Those who plan to smoke during the study period.
Those who have hypersensitivity to test food.
Those who have a history of drug allergy or food allergy.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kiyotaka
Middle name
Last name Hori

Organization

Santen Pharmaceutical Co., Ltd.

Division name

Japan Medical Affairs

Zip code

5308552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9337

Email

clinical@santen.co.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

Zip code

5308552

Address

4-20, Ofukacho, Kita-ku, Osaka

TEL

06-4802-9337

Homepage URL


Email

clinical@santen.co.jp


Sponsor or person

Institute

Santen Pharmaceutical Co., Ltd.

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

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.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

2021 Year 07 Month 20 Day


Related information

URL releasing protocol

Not applicable

Publication of results

Unpublished


Result

URL related to results and publications

Not applicable

Number of participants that the trial has enrolled

59

Results

This study did not meet primary endpoint.

Results date posted

2022 Year 06 Month 07 Day

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

2021 Year 05 Month 18 Day

Date of IRB

2021 Year 05 Month 25 Day

Anticipated trial start date

2021 Year 06 Month 29 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 19 Day

Last modified on

2022 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name