A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000025565
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Schirmer's test (the average of right and left eyes)
- Secondary Outcome Measures
Name Time Method 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