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

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 Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Prosicca; Other: Bacterial culture; Drug: Prosicca sine

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Clinical Pharmacology, Medical University of Vienna
    • Contact: Gerhard Garhoefer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged between 18 and 75 years.
• Signed and dated written informed consent.
• History of dry eye syndrome for at least 3 months
• Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm and ≥ 2mm
• Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
• Recommended use of topical lubricants, but no administration of topical lubricants 4 weeks preceding the first study day.

Exclusion Criteria:

• History or presence of ocular disease judged by the investigator as incompatible with the study.
• Any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period.
• Wearing of contact lenses.
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day.
• Participation in a clinical trial in the 3 weeks preceding the first study day.
• Pregnancy, lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAC treatment group; 20 patients with mild or moderate dry eye syndrome receiving BAC containing Prosicca eyedrops for 1 month	Drug: Prosicca; Prosicca eyedrops Dosage: on demand Route of administration: topical; Other: Bacterial culture; bacterial cultures obtained with conjunctival swabs
Active Comparator: non-BAC treatment group; 20 patients with mild or moderate dry eye syndrome receiving preservative-free Prosicca sine eyedrops for 1 month	Other: Bacterial culture; bacterial cultures obtained with conjunctival swabs; Drug: Prosicca sine; Prosicca sine eyedrops Dosage: on demand Route of administration: topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of colony forming units (CFU) in bacterial culture of conjunctival swab	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Tear Break Up Time (BUT)	1 month
Schirmer I test	1 month
OSDI© score	1 month
Instillation frequency	1 month

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2015
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: OPHT-280515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No