Safety and 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:
NCT01015209
First received: November 17, 2009
Last updated: September 24, 2012
Last verified: September 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.


Condition Intervention Phase
Dry Eye Syndromes
Device: 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: Single Blind (Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1: 18 healthy subjects
18 healthy subjects receiving Chitosan- N- Acetylcysteine eye drops at a dose of 0.1%, 0.2% or 0.3% (6 subjects per group)
Device: Chitosan- N- Acetylcysteine eye drops
Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days
Active Comparator: Cohort 2: 12 healthy patients
12 healthy subjects receiving Chitosan- N- Acetylcysteine eye drops at a dose of 0.1%, 0.2% or 0.3%
Device: Chitosan- N- Acetylcysteine eye drops
Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

  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 of 6 or more 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: NCT01015209

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. Priv.-Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01015209     History of Changes
Other Study ID Numbers: OPHT- 141009
Study First Received: November 17, 2009
Last Updated: September 24, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Dry eye syndromes

Additional relevant MeSH terms:
Syndrome
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Ophthalmic Solutions
Acetylcysteine
N-monoacetylcystine
Chitosan
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 02, 2014