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Clinical trial

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

ID
Name
97-01-104-18912
Description
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.
Trial arms
Trial start
2021-07-01
Estimated PCD
2022-06-30
Trial end
2022-07-30
Status
Completed
Phase
Early phase I
Treatment
Ophthalmic Probiotic
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
Arms:
Ophthalmic probiotic, Opthalmic Probiotic + Oral Probiotic
Opthalmic Placebo
Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei (i.e. HPMC, boric acid, sodium chloride, purified water)
Arms:
Oral Probiotic, Placebo
Oral Probiotic Capsule
Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient
Arms:
Opthalmic Probiotic + Oral Probiotic, Oral Probiotic
Oral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient
Arms:
Ophthalmic probiotic, Placebo
Size
40
Primary endpoint
Ocular Surface Disease Index
4 weeks
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-03-27

1 organization

2 products

1 indication

Organization
Shiraz University of Medical Sciences
Product
Ophthalmic Probiotic
Indication
Dry Eye Syndrome
Product
Opthalmic