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

Efficacy and Safety of Ophthalmic Probiotic Lysate on Ocular Surface Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110811007297N8
Enrollment
40
Registered
2022-05-22
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye syndrome. dry eye syndrome

Interventions

Intervention 1: Intervention group: ophthalmic probiotic drop, 1 drop Q6h, for 4 weeks. Intervention 2: Control group: ophthalmic placebo drop, 1 drop Q6h, for 4 weeks.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Male or Female 18=9/10 Signed informed consent Voluntary adherence to treatment

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Heydari

Shiraz University of Medical Sciences

mheydari@sums.ac.ir+98 71 1235 7679

Outcome results

None listed

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