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

NCT01015209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-09-25

No results posted yet for this study

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

DEVICE

Chitosan- N- Acetylcysteine eye drops

Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-10-31
Completion
2011-01-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015209 on ClinicalTrials.gov