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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01278784
First received: December 20, 2010
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndromes
Device: 0.05% Chitosan-N-Acetylcysteine eye drops
Device: 0.1% Chitosan-N-Acetylcysteine eye drops
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy volunteer 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 less than 6 dpt
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278784

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01278784     History of Changes
Other Study ID Numbers: OPHT-141010
Study First Received: December 20, 2010
Last Updated: December 7, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Dry eye syndromes
Chitosan-N-Acetylcysteine

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Acetylcysteine
N-monoacetylcystine
Tetrahydrozoline
Chitosan
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents

ClinicalTrials.gov processed this record on July 28, 2014