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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 20, 2010
Last Updated Date	December 7, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 18, 2011)	Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01278784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Official Title ^ICMJE	Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Dry Eye Syndromes
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Healthy volunteer Interventions: Device: 0.05% Chitosan-N-Acetylcysteine eye drops Device: 0.1% Chitosan-N-Acetylcysteine eye drops
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	September 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT01278784
Other Study ID Numbers ^ICMJE	OPHT-141010
Has Data Monitoring Committee	Yes
Responsible Party	Gerhard Garhofer, Medical University of Vienna
Study Sponsor ^ICMJE	Medical University of Vienna
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medical University of Vienna
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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