Probiotic in Dry Eye Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Ophthalmic probiotic

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

Group Type EXPERIMENTAL

Ophthalmic Probiotic

Intervention Type DRUG

Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.

Oral Placebo Capsule

Intervention Type DIETARY_SUPPLEMENT

Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Placebo

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

Group Type PLACEBO_COMPARATOR

Opthalmic Placebo

Intervention Type DRUG

Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei (i.e. HPMC, boric acid, sodium chloride, purified water)

Oral Placebo Capsule

Intervention Type DIETARY_SUPPLEMENT

Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Opthalmic Probiotic + Oral Probiotic

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

Group Type EXPERIMENTAL

Ophthalmic Probiotic

Intervention Type DRUG

Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.

Oral Probiotic Capsule

Intervention Type DIETARY_SUPPLEMENT

Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient

Oral Probiotic

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

Group Type EXPERIMENTAL

Opthalmic Placebo

Intervention Type DRUG

Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei (i.e. HPMC, boric acid, sodium chloride, purified water)

Oral Probiotic Capsule

Intervention Type DIETARY_SUPPLEMENT

Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient

Interventions

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Ophthalmic Probiotic

Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.

Intervention Type 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)

Intervention Type DRUG

Oral Probiotic Capsule

Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient

Intervention Type DIETARY_SUPPLEMENT

Oral Placebo Capsule

Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No