Probiotic in Dry Eye Syndromes

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04938908
Collaborator
(none)
40
1
4
12
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ophthalmic Probiotic
  • Drug: Opthalmic Placebo
  • Dietary Supplement: Oral Probiotic Capsule
  • Dietary Supplement: Oral Placebo Capsule
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ophthalmic probiotic

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

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

Dietary Supplement: Oral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Placebo Comparator: Placebo

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

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)

Dietary Supplement: Oral Placebo Capsule
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Experimental: Opthalmic Probiotic + Oral Probiotic

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

Drug: Ophthalmic Probiotic
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (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

Experimental: Oral Probiotic

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

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)

Dietary Supplement: Oral Probiotic Capsule
Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient

Outcome Measures

Primary Outcome Measures

  1. Ocular Surface Disease Index [4 weeks]

    Subjective score

Secondary Outcome Measures

  1. Tear break up time (TBUT) [4 weeks]

    Slit exam

  2. Schirmer test [4 weeks]

    physical exam using Schirmer strip

  3. Ocular surface microbiota composition [4 weeks]

    measured by 16s rRNA method

  4. Tear Interleukin level [4 weeks]

    measured by ELISA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mojtaba Heydari, Principal Investigator, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04938908
Other Study ID Numbers:
  • 97-01-104-18912
First Posted:
Jun 25, 2021
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022