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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT02533154
Collaborator
(none)
40
2
2
98.2
20
0.2

Study Details

Study Description

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 Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients
Actual Study Start Date :
Jul 27, 2015
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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

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

Other: Bacterial culture
bacterial cultures obtained with conjunctival swabs

Outcome Measures

Primary Outcome Measures

  1. Number of colony forming units (CFU) in bacterial culture of conjunctival swab [1 month]

Secondary Outcome Measures

  1. Tear Break Up Time (BUT) [1 month]

  2. Schirmer I test [1 month]

  3. OSDI© score [1 month]

  4. Instillation frequency [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090
2 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02533154
Other Study ID Numbers:
  • OPHT-280515
First Posted:
Aug 26, 2015
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
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 Apr 7, 2022