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A human trial to evaluate the efficacy and safety of SGF500 on dry eye

A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of SGF500 on dry eye

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007043
Enrollment
80
Registered
2022-03-04
Start date
2021-12-13
Completion date
Unknown
Last updated
2022-03-08

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 : • SGF500 group: 1 times a day, 1 capsule once, before breakfast for 12 weeks{350 mg/day (Bacillus amyloliquefaciens spore: 1 x 10^9 CFU/day, GF101 500 U/day)} • Placebo group: 1

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index;tear break-up time

Secondary

MeasureTime frame
Visual analog scale;Schirmer’s test;Meibomian gland test;Fluorescein staining;inflammatory outcome;antioxidant outcome

Countries

Korea, Republic of

Contacts

Public ContactIn Cheon You

Jeonbuk National University Hospital

you2ic@daum.net+82-63-250-2581

Outcome results

None listed

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