Skip to main content
OpenTrials
Completed

NCT Number: NCT01015209

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chitosan- N- Acetylcysteine eye drops

Device

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

Primary outcomes

  1. Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 18, 2009
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.