Efficacy and Safety of Ophthalmic Probiotic Lysate on Ocular Surface of Patients With Dry Eye Syndrome

Phase 2

Recruiting

• Conditions: Dry eye syndrome.; dry eye syndrome; H04. 12

• Registration Number: IRCT20110811007297N8
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Male or Female
18Best corrected vision>=9/10
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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index. Timepoint: 4 weeks. Method of measurement: questionnaire.;Tear break up time (TBUT). Timepoint: 4 weeks. Method of measurement: Slit exam with fluorescein staining.;Schirmer test. Timepoint: 4 weeks. Method of measurement: Physical exam with Schirmer strip.;Ocular surface microbiota composition. Timepoint: 4 weeks. Method of measurement: Measured by 16s rRNA method.;Tear Interleukin level. Timepoint: 4 weeks. Method of measurement: ELISA.