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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000035790 |
Receipt No. | R000040771 |
Official scientific title of the study | 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 | 2019/02/06 |
Basic information | ||
Official scientific title of the study | 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. | |
Title of the study (Brief title) | Effect of supplement on accommodation of eye. | |
Region |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |
Name of lead principal investigator | Kei Yui |
Organization | FANCL Corporation |
Division name | Research Institute, Health science research center |
Address | 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa |
TEL | 045-820-3755 |
ke-yui@fancl.co.jp |
Public contact | |
Name of contact person | Shimpei Tomita |
Organization | New drug research center, Inc. |
Division name | R&D Center, Research Dept., Clinical Research Dept. |
Address | 452-1Toiso,Eniwa-shi,Hokkaido, Japan |
TEL | 0123-34-0412 |
Homepage URL | |
s-tomita@ndrcenter.co.jp |
Sponsor | |
Institute | New Drug Research Center Inc. |
Institute | |
Department |
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) |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Last follow-up date | |||||||
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Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040771 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |