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A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial

A verification study for improvement in eye dryness: A randomized double-blind placebo-controlled trial - A verification study for improvement in eye dryness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025565
Enrollment
70
Registered
2017-07-22
Start date
2016-11-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

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 Dur

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Ario Nishiarai Eye Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Schirmer's test (the average of right and left eyes)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026