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A 12-week randomized, double-blind, placebo-controlled pilot trial to evaluate the efficacy and safety of eyecare on improving eye health in the elderly

Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of 16 Weeks of Intake of Eyecare in Patients with Early Macular Degeneration

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008902
Enrollment
18
Registered
2023-10-27
Start date
2018-01-23
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

Dietary Supplement : *eyecare • Main Component: eyecare 450mg/capsule • Weight: 490mg/capsule • Usage and Capacity: Intake 1 capsule/time and twice a day • Intake period: 16-weeks * Placebo • Main C

Sponsors

AltRegen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult men and women over 50 years of age. 2) Individuals who have voluntarily agreed to participate in this study and have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Those with significant retinal diseases other than macular degeneration. 2) Those with local or systemic inflammatory diseases such as autoimmune diseases. 3) Those taking systemic steroids or immunosuppressants. 4) Those with ophthalmic clinical findings due to acute or chronic cardiovascular, cerebrovascular, endocrine, immune, respiratory, hepatobiliary, kidney and urinary, neuropsychiatric, musculoskeletal, inflammatory, and blood/neoplastic diseases. 5) Patients with uncontrolled diabetes. 6) Those who have a history of hypersensitivity or clinically significant hypersensitivity to drugs and human testing products. 7) Those who have undergone gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (except for appendectomy or hernia surgery) that may affect the absorption of the product for human application test. 8) A person who shows the following results in a diagnostic medical test: ? AST, ALT > 2 times the upper limit of the normal range. ? Serum creatinine > 2.0 mg/dL. 9) A person with a history of or suspected alcoholism or drug abuse. 10) Pregnant women, lactating women, or women of childbearing age who do not use appropriate contraceptive methods. 11) Those who have participated in other clinical trial within the last 2 months. 12) Other individuals who are judged to be unable to participate in the human application test, according to the judgment of the tester.

Design outcomes

Primary

MeasureTime frame
Speed of recovery of rod cells and scotopic response;Advers event

Secondary

MeasureTime frame
Macular thickness;Best corrected visual acuity;Ocular Surface Disease Index (OSDI);Visual function questionnaire score (Korean version of the visual function questionnaire; VFQ-25);tear secretion;Laboratory tests (hematology, blood chemistry, urinalysis);vital sign

Countries

Korea, Republic of

Contacts

Public ContactEun-Soo Jung

Jeonbuk National University Hospital

esjung@jbctc.org+82-63-259-3049

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026