Dry Eye Syndrome Clinical Trial
In the elderly population, dry eye syndrome is a highly prevalent ocular disease. One
mainstay of therapy for patients suffering from dry eye syndrome is the use of topically
administered lubricants. One of the main disadvantages of the formulations currently
available for the treatment of DES is the short residency time on the ocular surface, which
increases the need for a frequent instillation of the lubricant.
Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for
treatment of symptoms related to DES. Based on theoretical considerations and animal
experiments, the new chitosan derivative may show an increased adhesion to mucins of the
ocular surface and may therefore considerably increase the residence on the ocular surface.
This, in turn, would limit the need for frequent treatment and decrease the burden for the
patients.
It has been shown in recent Phase I studies that chitosan-N-acetylcysteine eye drops are
safe and well tolerated after single and repeated instillation. The current study seeks to
investigate the ocular residency time after a single dose and after 5 day b.i.d. treatment.
For this purpose 2 cohorts are planned: In Cohort I, chitosan-N-acetylcysteine eye drops
will be instilled once in one randomly chosen eye, whereas the fellow eye will receive
placebo. Measurements of tear film thickness will be performed with optical coherence
tomography (OCT) before instillation and 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10
hours, 12 hours and 24 hours after instillation. In addition, ocular scattering of the tear
film will be assessed with an Optical Quality Analysis System (OQAS) at the same timepoints.
Determination of break up time (BUT) will be performed before and after instillation of the
eye drops.
In Cohort II, chitosan-N-acetylcysteine eye drops will be instilled once daily in one eye
and b.i.d. in the fellow eye on five consecutive days. Measurements of tear film thickness
with OCT and OQAS will be performed every study day before the morning instillation and the
day after the last instillation. Additionally, patients will be asked to answer the ocular
surface disease index (OSDI©) on day 1 and day 6. BUT will be determined before and after
instillation of the eye drops.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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