UMIN-CTR Clinical Trial

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
Institute	Santen Pharmaceutical Co., Ltd.
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051236