Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Eye Syndromes
Intervention: 0.05% Chitosan-N-Acetylcysteine eye drops (Device); 0.1% Chitosan-N-Acetylcysteine eye drops (Device)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Medical University of Vienna Overall contact:
Gerhard Garhofer, MD, Ass.-Prof., Phone: 0043 1 40400, Ext: 2981, Email: gerhard.garhoefer@meduniwien.ac.at
Summary
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.
Clinical Details
Official title: Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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 less than 6 dpt
- Pregnancy
Locations and Contacts
Gerhard Garhofer, MD, Ass.-Prof., Phone: 0043 1 40400, Ext: 2981, Email: gerhard.garhoefer@meduniwien.ac.at
Department of Clinical Pharmacology, Medical University of Vienna, Vienna 1090, Austria
Additional Information
Starting date: March 2011
Last updated: January 18, 2011
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