A Phase 4 interventional study of Prosicca and Prosicca sine in Dry Eye Syndromes, sponsored by Medical University of Vienna. Status unknown at 2 sites in Austria. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Medical University of Vienna · Phase 4, Interventional, and Basic science
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 Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.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.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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Exclusion Criteria:
20 patients with mild or moderate dry eye syndrome receiving BAC containing Prosicca eyedrops for 1 month
Drug: Prosicca · Other: Bacterial culture
20 patients with mild or moderate dry eye syndrome receiving preservative-free Prosicca sine eyedrops for 1 month
Drug: Prosicca sine · Other: Bacterial culture
Prosicca eyedrops Dosage: on demand Route of administration: topical
Prosicca sine eyedrops Dosage: on demand Route of administration: topical
bacterial cultures obtained with conjunctival swabs
Number of colony forming units (CFU) in bacterial culture of conjunctival swab
Time frame: 1 month
Tear Break Up Time (BUT)
Time frame: 1 month
Schirmer I test
Time frame: 1 month
OSDI© score
Time frame: 1 month
Instillation frequency
Time frame: 1 month
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna →