Probiotic in Dry Eye Syndromes
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Ophthalmic probiotic 1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks |
Drug: Ophthalmic Probiotic
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
Dietary Supplement: Oral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient
|
Placebo Comparator: Placebo 1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks |
Drug: 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)
Dietary Supplement: Oral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient
|
Experimental: Opthalmic Probiotic + Oral Probiotic 1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks |
Drug: Ophthalmic Probiotic
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
Dietary Supplement: Oral Probiotic Capsule
Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient
|
Experimental: Oral Probiotic 1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks |
Drug: 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)
Dietary Supplement: Oral Probiotic Capsule
Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient
|
Outcome Measures
Primary Outcome Measures
- Ocular Surface Disease Index [4 weeks]
Subjective score
Secondary Outcome Measures
- 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
Eligibility Criteria
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
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Signed informed consent, voluntary adherence to treatment
Exclusion Criteria:
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Pregnancy/breastfeeding
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Conjunctivitis
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Thyroid disease
-
Diabetes
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Rheumatologic diseases including Sjogren's syndrome
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Neurologic conditions, including stroke, Bell's palsy, Parkinson's, trigeminal nerve problem
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Refractive surgery (LASIK or PRK)
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Other Eye Surgeries
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HSV Keratitis
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Medication/supplement use, including psychiatric medicines, OTC cold medicines, anti-histamines, beta-blockers, pain relievers, sleeping pills, diuretics, Hormones replacement, and oral contraceptives
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Chemical splashes / injuries to the eyes
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Contact lens use
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Environmental (dusty, windy, hot/dry)
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Any treatment for dry eye in previous 4 weeks (including lubricants, steroids, cyclosporine)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences | Shiraz | Fars | Iran, Islamic Republic of |
Sponsors and Collaborators
- Shiraz University of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 97-01-104-18912