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
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0008902
- Lead Sponsor
- AltRegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Speed of recovery of rod cells and scotopic response;Advers event
- Secondary Outcome Measures
Name Time Method 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