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
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
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
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
