NCT04938908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

June 22, 2021

Last Update Submit

March 24, 2023

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index

    Subjective score

    4 weeks

Secondary Outcomes (4)

  • Tear break up time (TBUT)

    4 weeks

  • Schirmer test

    4 weeks

  • Ocular surface microbiota composition

    4 weeks

  • Tear Interleukin level

    4 weeks

Study Arms (4)

Ophthalmic probiotic

EXPERIMENTAL

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

Drug: Ophthalmic ProbioticDietary Supplement: Oral Placebo Capsule

Placebo

PLACEBO COMPARATOR

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

Drug: Opthalmic PlaceboDietary Supplement: Oral Placebo Capsule

Opthalmic Probiotic + Oral Probiotic

EXPERIMENTAL

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

Drug: Ophthalmic ProbioticDietary Supplement: Oral Probiotic Capsule

Oral Probiotic

EXPERIMENTAL

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

Drug: Opthalmic PlaceboDietary Supplement: Oral Probiotic Capsule

Interventions

Ophthalmic ProbioticDRUG

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

Ophthalmic probioticOpthalmic Probiotic + Oral Probiotic
Opthalmic PlaceboDRUG

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 ProbioticPlacebo
Oral Probiotic CapsuleDIETARY_SUPPLEMENT

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

Opthalmic Probiotic + Oral ProbioticOral Probiotic
Oral Placebo CapsuleDIETARY_SUPPLEMENT

Hydroxypropylmethylcellulose hard capsule, filled with maltodextrin excipient

Ophthalmic probioticPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female
  • \<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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shiraz, Fars, Iran

Location

Related Publications (1)

  • Heydari M, Kalani M, Ghasemi Y, Nejabat M. The Effect of Ophthalmic and Systemic Formulations of Latilactobacillus sakei on Clinical and Immunological Outcomes of Patients With Dry Eye Disease: A Factorial, Randomized, Placebo-controlled, and Triple-masking Clinical Trial. Probiotics Antimicrob Proteins. 2024 Jun;16(3):1026-1035. doi: 10.1007/s12602-023-10079-1. Epub 2023 May 31.

    PMID: 37256485DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 25, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)