Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
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 Unpublished data from our department shows differences between artificial tears for the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.