Dry Eye Syndromes Clinical Trial
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Men and women aged between 18 and 45 years - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal ophthalmic findings, ametropia < 6 dpt. Exclusion Criteria: - Participation in a clinical trial in the 3 weeks preceding the study - Abuse of alcoholic beverages - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Ametropia of 6 or more dpt. - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Austria | Department of Clinical Pharmacology, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops | 5 weeks | No |
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