UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035790 |
|---|---|
| Receipt number | R000040771 |
| Scientific Title | Effect of the supplement on accommodation of eye in middle- and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study. |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/08/10 13:20:13 |
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Basic information
Public title
Effect of the supplement on accommodation of eye in middle- and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Acronym
Effect of supplement on accommodation of eye.
Scientific Title
Effect of the supplement on accommodation of eye in middle- and old-aged adults : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Scientific Title:Acronym
Effect of supplement on accommodation of eye.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the improvement of accommodation of eye in middle and old-aged adults who are perceiving eye fatigue after administration of supplement for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accommodation of eye (4 weeks after ingestion)
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
Ingestion of test food for 4 weeks
Interventions/Control_2
Ingestion of placebo for 4 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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. From 35 to 64 years old
2. Binocular vision is more than 1.0 at naked or corrected eyesight . The specifications of eye-contact lens or glasses cannot be changed and replaced with new ones during the test period.
3. Have no eye diseases other than refractive error (near-sightedness, far-sightedness and astigmatism)
4. Near point distance is lower than the age average.
5. The person who can go to facilities on check days
6.Written informed consent
Key exclusion criteria
1. Risk of onset of pollen allergy during the study period (February to April)
2. Conduct of lasik surgery during the past 6 months
3. Presence or history of hepatitis diseases or severe renal, endocrine, cardiovascular, gastric, lung, hematologic and metabolic disorder diseases
4. Current medications (excluding on-demand use)
5. Can't stop to take a supplement during the study period.
6. Presence or history of drug/food allergy
7. Receipt of investigational product in other clinical studies during the past one month or currently participating in other clinical studies
8. Female who is pregnant, breast-feeding or intends to become pregnant
9. Patients whom principal investigator judges inappropriate to invite to this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimpei Tomita |
Organization
New drug research center, Inc.
Division name
R&D Center, Research Dept., Clinical Research Dept.
Zip code
Address
452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
New Drug Research Center Inc.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
Address
Tel
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
浜田山ファミリークリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 07 | 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
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 | 02 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 06 | Day |
Last modified on
| 2019 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040771
