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Completed

NCT Number: NCT04938908

Probiotic in Dry Eye Syndromes

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ophthalmic Probiotic

Drug

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

Opthalmic Placebo

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

Dietary Supplement

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

Oral Placebo Capsule

Dietary Supplement

Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Primary outcomes

  1. Ocular Surface Disease Index

    Time frame: 4 weeks

    Subjective score

Secondary outcomes

  1. Tear break up time (TBUT)

    Time frame: 4 weeks

    Slit exam

  2. Schirmer test

    Time frame: 4 weeks

    physical exam using Schirmer strip

  3. Ocular surface microbiota composition

    Time frame: 4 weeks

    measured by 16s rRNA method

  4. Tear Interleukin level

    Time frame: 4 weeks

    measured by ELISA

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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