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Probiotic in Dry Eye Syndromes

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ophthalmic Probiotic
Opthalmic Placebo
Oral Probiotic Capsule
Oral Placebo Capsule
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Ophthalmic probiotic

Placebo

Opthalmic Probiotic + Oral Probiotic

Oral Probiotic

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Ocular Surface Disease Index
Subjective score

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2021
Last Updated
March 24, 2023
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04938908
Brief Title
Probiotic in Dry Eye Syndromes
Official Title
Efficacy and Safety of Systemic and Ophthalmic Probiotic on Microbiota, Immunological and Clinical Outcomes of Patients With Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ophthalmic probiotic
Arm Type
Experimental
Arm Description
1 active drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 placebo drop in each eye/ 5 hours plus oral placebo capsule, for 4 weeks
Arm Title
Opthalmic Probiotic + Oral Probiotic
Arm Type
Experimental
Arm Description
1 active drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
Arm Title
Oral Probiotic
Arm Type
Experimental
Arm Description
1 placebo drop in each eye/ 5 hours plus oral probiotic capsule, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Ophthalmic Probiotic
Intervention Description
Bacterial lysate of Lactobacillus sakei, hydroxypropylmethylcellulose (HPMC), boric acid, sodium chloride, purified water.
Intervention Type
Drug
Intervention Name(s)
Opthalmic Placebo
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Oral Probiotic Capsule
Intervention Description
Live Lactobacillus sakei (5 billion cfus) in hydroxypropylmethylcellulose hard capsule, with maltodextrin excipient
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Placebo Capsule
Intervention Description
Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
Subjective score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Tear break up time (TBUT)
Description
Slit exam
Time Frame
4 weeks
Title
Schirmer test
Description
physical exam using Schirmer strip
Time Frame
4 weeks
Title
Ocular surface microbiota composition
Description
measured by 16s rRNA method
Time Frame
4 weeks
Title
Tear Interleukin level
Description
measured by ELISA
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Research Center for Traditional Medicine and History of Medicine-Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotic in Dry Eye Syndromes

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