Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers

Phase 1

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Chitosan- N- Acetylcysteine eye drops

• Registration Number: NCT01015209
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Study Start: 2010-09
• Primary Completion: 2010-10
• Study Completion: 2011-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1: 18 healthy subjects	Chitosan- N- Acetylcysteine eye drops	18 healthy subjects receiving Chitosan- N- Acetylcysteine eye drops at a dose of 0.1%, 0.2% or 0.3% (6 subjects per group)
Cohort 2: 12 healthy patients	Chitosan- N- Acetylcysteine eye drops	12 healthy subjects receiving Chitosan- N- Acetylcysteine eye drops at a dose of 0.1%, 0.2% or 0.3%

Primary Outcome Measures

Name	Time	Method
Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops	5 weeks

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria