Dry Eye Syndromes Clinical Trial
Official title:
Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the
elderly population. One mainstay of therapy for patients suffering from DES is the use of
topically administered lubricants. However, despite many efforts, no "ideal" formulation has
yet been found.
Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for
treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with
favourable biological properties such as high biocompatibility and low toxicity.
Additionally, the new formulation comprises N-acetylcysteine, which has been used in
ophthalmology because of its mucolytic properties for several years. Based on theoretical
considerations, one can hypothesize that the new chitosan derivative may show an increased
adhesion to mucins of the ocular surface and may therefore be particularly beneficial in
reducing the symptoms associated with DES. We have recently shown in a phase I trial that
single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young
healthy subjects. However, due to the fact that intraocular pressure has been measured as
one of the main safety variables, topical anesthesia was necessary. Thus, the data about
local ocular discomfort after administration are limited. This trial seeks to investigate
whether single instillation of chitosan-N-acetylcystein leads to ocular discomfort such as
burning and stinging.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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