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

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ClinicalTrials.gov Identifier: NCT02533154
Recruitment Status : Not yet recruiting
First Posted : August 26, 2015
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

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 Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.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
Dry Eye Syndromes Drug: Prosicca Drug: Prosicca sine Other: Bacterial culture Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of colony forming units (CFU) in bacterial culture of conjunctival swab [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Tear Break Up Time (BUT) [ Time Frame: 1 month ]
  2. Schirmer I test [ Time Frame: 1 month ]
  3. OSDI© score [ Time Frame: 1 month ]
  4. Instillation frequency [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533154


Contacts
Contact: Gerhard Garhöfer, MD +43 1 40400 ext 29810 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

Responsible Party: Gerhard Garhofer, Assoc. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02533154     History of Changes
Other Study ID Numbers: OPHT-280515
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Benzalkonium Compounds
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents