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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278784
First Posted: January 19, 2011
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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 Gerhard Garhofer, Medical University of Vienna:

Primary Outcome Measures:
  • Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops [ Time Frame: 6 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278784


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

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
First Submitted: December 20, 2010
First Posted: January 19, 2011
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Gerhard Garhofer, 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
Ophthalmic Solutions
Tetrahydrozoline
Acetylcysteine
N-monoacetylcystine
Chitosan
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes