NCT01015209

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Chitosan- N- Acetylcysteine eye drops	Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-10-01
• Completion: 2011-01-01
• First posted: 2009-11-18
• Last updated: 2012-09-25

Locations

1 site across 1 country: Austria