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Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients

NCT02533154 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-04-07

No results posted yet for this study

Summary

Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. Several studies have indicated that BAC may also have altering effects on the bacterial flora of the conjunctiva.

Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular surface and the tear fluid resulting in tear film instability, inflammation of the ocular surface, symptoms of discomfort and visual impairment, there are many different preserved as well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of DES. Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.

Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study will be recruited and treated either with the preservative-free "Prosicca sine" eyedrops or the BAC containing "Prosicca" eyedrops for one month. Conjunctival samples will be collected of one eye of each patient before and after the 1-month treatment period to compare the conjunctival bacterial flora of the two treatment groups.

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Prosicca

Prosicca eyedrops Dosage: on demand Route of administration: topical

DRUG

Prosicca sine

Prosicca sine eyedrops Dosage: on demand Route of administration: topical

OTHER

Bacterial culture

bacterial cultures obtained with conjunctival swabs

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-27
Primary Completion
2023-09-30
Completion
2023-10-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533154 on ClinicalTrials.gov