Probiotic in Dry Eye Syndromes

Dry Eye Syndrome Clinical Trial

Official title:

Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938908
• Other study ID #: 97-01-104-18912
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: March 2023
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Ophthalmic Probiotic
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
• 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
• Oral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Locations

Country	Name	City	State
Iran, Islamic Republic of	Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index	Subjective score	4 weeks
Secondary	Tear break up time (TBUT)	Slit exam	4 weeks
Secondary	Schirmer test	physical exam using Schirmer strip	4 weeks
Secondary	Ocular surface microbiota composition	measured by 16s rRNA method	4 weeks
Secondary	Tear Interleukin level	measured by ELISA	4 weeks