A human trial to evaluate the efficacy and safety of SGF500 on dry eye
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0007043
- Lead Sponsor
- Jeonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) OSDI =13 at screening test
2) TBUT=10 or (+) on Fluorescein staining at screening test
3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions
1) Patients with a clinically significant disease requiring treatment (i.e., cardiovascular system, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.)
2) Patients with a history of antipsychotic medication use within 3 months prior to the screening examination
3)Patients who have participated in other clinical trials within 3 months prior to the screening examination
4)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular Surface Disease Index;tear break-up time
- Secondary Outcome Measures
Name Time Method Visual analog scale;Schirmer’s test;Meibomian gland test;Fluorescein staining;inflammatory outcome;antioxidant outcome