Clinical trial NCT04938908: Probiotic in Dry Eye Syndromes
Official title: Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The ocular surface is comprised of the cornea and its overlying tissue, the conjunctiva. The ocular surface is continuously exposed to the external environment and, therefore, to different microbial species. A resident ocular surface microbiota has been found in various studies. Although little is known so far, some elements of this microbiota and/or its metabolites could represent protective cofactosr in the pathogenesis of common ocular diseases.

On the other hand, the gut microbiota is known to influence host homeostasis in distal tissues, such as brain (gut-barin axis), lungs (gut-lungs axis) and skin (gut-skin axis). However, little is known about distal effects of the gut microbiota on the ocular surface.

In this study we sought to evaluate the efficacy and safety aspects of L.sakei as both ophtalmic probiotic lysate and oral live probiotic on Dry Eye Syndrome, using a factorial design, against placebo.

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)

Primary outcomes:
measure: Ocular Surface Disease Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Tear break up time (TBUT)
timeFrame: 4 weeks
measure: Schirmer test
timeFrame: 4 weeks
measure: Ocular surface microbiota composition
timeFrame: 4 weeks
measure: Tear Interleukin level
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences
state: Fars
Study officials:
References: