Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT02802150
Eligibility Criteria:
Inclusion criteria:
* men and women
* 20 to 70 years with dry eye disease
* low tear break-up time (TBUT) (\<10 seconds) or low Schirmer score (with application of local anesthetic) (\<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening.
* blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively.
Exclusion Criteria:
* under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin)
* hypolipidemic medication within 3 months of study entry
* history of chronic disease
* any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study
* allergic or hypersensitive to any of the ingredients in the test products.
* women who were pregnant or breast feeding
* a history of alcoholism or drug abuse or medical or psychological conditions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02802150
Study Brief:
Protocol Section:
NCT02802150