Probiotic in Dry Eye Syndromes

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Ophthalmic Probiotic; Drug: Opthalmic Placebo; Dietary Supplement: Oral Placebo Capsule; Dietary Supplement: Oral Probiotic Capsule

• Registration Number: NCT04938908
• Lead Sponsor: Shiraz University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-25
• Study Start: 2021-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Oral Placebo Capsule	1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
Opthalmic Probiotic + Oral Probiotic	Oral Probiotic Capsule	1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
Ophthalmic probiotic	Oral Placebo Capsule	1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
Ophthalmic probiotic	Ophthalmic Probiotic	1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
Placebo	Opthalmic Placebo	1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
Opthalmic Probiotic + Oral Probiotic	Ophthalmic Probiotic	1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
Oral Probiotic	Opthalmic Placebo	1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
Oral Probiotic	Oral Probiotic Capsule	1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index	4 weeks	Subjective score

Secondary Outcome Measures

Name	Time	Method
Ocular surface microbiota composition	4 weeks	measured by 16s rRNA method
Tear Interleukin level	4 weeks	measured by ELISA
Tear break up time (TBUT)	4 weeks	Slit exam
Schirmer test	4 weeks	physical exam using Schirmer strip

Trial Locations

Locations (1)

Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of