Probiotic in Dry Eye Syndromes

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: Opthalmic Placebo; Dietary Supplement: Oral Probiotic Capsule; Drug: Ophthalmic Probiotic; Dietary Supplement: Oral Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04938908

97-01-104-18912

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

Ophthalmic probiotic

Experimental group

Description:

1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks

Treatment:

Drug: Ophthalmic Probiotic

Dietary Supplement: Oral Placebo Capsule

Placebo

Placebo Comparator group

Description:

1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks

Treatment:

Drug: Opthalmic Placebo

Dietary Supplement: Oral Placebo Capsule

Opthalmic Probiotic + Oral Probiotic

Experimental group

Description:

1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks

Treatment:

Dietary Supplement: Oral Probiotic Capsule

Drug: Ophthalmic Probiotic

Oral Probiotic

Experimental group

Description:

1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks

Treatment:

Drug: Opthalmic Placebo

Dietary Supplement: Oral Probiotic Capsule