![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000025565 |
Receipt No. | R000029421 |
Scientific Title | A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial |
Date of disclosure of the study information | 2017/07/22 |
Last modified on | 2017/10/10 |
Basic information | ||
Public title | A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial | |
Acronym | A verification study for improvement in eye dryness | |
Scientific Title | A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial | |
Scientific Title:Acronym | A verification study for improvement in eye dryness | |
Region |
|
Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the improvement effects for eye dryness and eye fatigue through ingestion of the test food |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Schirmer's test (the average of right and left eyes) |
Key secondary outcomes | 1. Schirmer's test (dominant and nondominant eyes, right and left eyes)
2. BUT (tear film break-up time) test 3. Subjective symptoms VAS (Visual Analogue Scale) DEQS (Dry Eye related Quality of life Score 4. Percentage of pupillary response 5. Flicker test 6. Doctor's observation |
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 | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Duration: 4 weeks
Test material: MaquiBright capsule Dose: 1 capsule for a day Administration: Take 1 capsule after breakfast *If you forget to take the capsule, take it during the same day |
|
Interventions/Control_2 | Duration: 4 weeks
Test material: Placebo capsule Dose: 1 capsule for a day Administration: Take 1 capsule after breakfast *If you forget to take the capsule, take it during the same day |
|
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. Those with eyes dryness
2. Those who suffer from eye fatigue 3. Those who usually play TV games, use PCs and/or a smart phone, or those who work on Visual Display Terminals (VDT) operation for four (4) hours or more per day 4. Those who have corrected vision of both eyes with 1.0 or more and who do not use contact lenses, or, those who can switch to using eye glasses during the test period |
|||
Key exclusion criteria | 1. At least one previous medical history of malignant tumors, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who were diagnosed dry eye syndrome 4. Those who changed the frequency of use artificial lachrymal fluid per day during the test period and use artificial lachrymal fluid seven times or more per day 5. Those who receive medication for dry eye syndrome (provided that a patient has not taken the medication for two (2) weeks and do not take medicines during the test period) 6. Those suffering from eye diseases (including conjunctivochalasis), and those who have previous medical history of eye diseases 7. Those who use eye drops for treatment of eye diseases 8. Those who are diagnosed with Sjogren's syndrome 9. Those who are susceptible to pollen allergy or are suffering from chronic asthma 10. Those who are receiving pharmacotherapy or who need pharmacotherapy 11. Those who suffer from meibomian gland dysfunction 12. Those who work late-night shift and the life-styles are irregular 13. Current use of medications (including herbal medicines) or/and supplements 14. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 15. Those who are allergic to medicines and/or the test food related products 16. Those who are pregnant, breast-feeding, or are expected to become pregnant during the test period 17. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 18. Others considered as inappropriate for this test by the doctor responsible for the test |
|||
Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | |||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo. | ||||||
TEL | 03-3818-0610 | ||||||
kazu@orthomedico.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | |||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | ORYZA OIL & FAT CHEMICAL CO., LTD.
Anklam Extrakt GmbH Maqui New Life S.A. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Ario Nishiarai Eye Clinic |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029421 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |