NCT01278784

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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. 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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	0.05% Chitosan-N-Acetylcysteine eye drops	Subjects will be randomized to receive one drop of the medical device in either the right or left eye
DEVICE	0.1% Chitosan-N-Acetylcysteine eye drops	Subjects will be randomized to receive one drop of the medical device in either the right or left eye

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-09-01
• First posted: 2011-01-19
• Last updated: 2012-12-10

Locations

1 site across 1 country: Austria