Dry Eye Syndrome
Conditions
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.
Interventions
DRUGOphthalmic Probiotic
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
DRUGOpthalmic 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)
DIETARY_SUPPLEMENTOral Probiotic Capsule
Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient
DIETARY_SUPPLEMENTOral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index | 4 weeks | Subjective score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear break up time (TBUT) | 4 weeks | Slit exam |
| Schirmer test | 4 weeks | physical exam using Schirmer strip |
| Ocular surface microbiota composition | 4 weeks | measured by 16s rRNA method |
| Tear Interleukin level | 4 weeks | measured by ELISA |
Countries
Iran
Outcome results
None listed