Dry Eye Syndrome Clinical Trial
Official title:
Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome
Verified date | March 2023 |
Source | Shiraz University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate efficacy and safety of systemic and ophthalmic probiotic from bacterial lysate of Lactobacillus sakei on microbiota, immunological and clinical outcomes of patients with Dry Eye Syndrome.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Male or Female - 18<age<60 - BCVA (Best Corrected Visual Acuity) >=9/10 - At least 2 subjective complaints compatible with dry eye - TBUT (Tear Break-Up Time) <= 10 sec, Schirmer's test <= 10mm - Signed informed consent, voluntary adherence to treatment Exclusion Criteria: - Pregnancy/breastfeeding - Conjunctivitis - Thyroid disease - Diabetes - Rheumatologic diseases including Sjogren's syndrome - Neurologic conditions, including stroke, Bell's palsy, Parkinson's, trigeminal nerve problem - Refractive surgery (LASIK or PRK) - Other Eye Surgeries - HSV Keratitis - Medication/supplement use, including psychiatric medicines, OTC cold medicines, anti-histamines, beta-blockers, pain relievers, sleeping pills, diuretics, Hormones replacement, and oral contraceptives - Chemical splashes / injuries to the eyes - Contact lens use - Environmental (dusty, windy, hot/dry) - Any treatment for dry eye in previous 4 weeks (including lubricants, steroids, cyclosporine) |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences | Shiraz | Fars |
Lead Sponsor | Collaborator |
---|---|
Shiraz University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular Surface Disease Index | Subjective score | 4 weeks | |
Secondary | Tear break up time (TBUT) | Slit exam | 4 weeks | |
Secondary | Schirmer test | physical exam using Schirmer strip | 4 weeks | |
Secondary | Ocular surface microbiota composition | measured by 16s rRNA method | 4 weeks | |
Secondary | Tear Interleukin level | measured by ELISA | 4 weeks |
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