Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses

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, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine in subjects wearing contact lenses. This is of special interest because the tear film is critical to successful contact lens wear. Disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. This trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Regular contact lens wear since 3 years minimum
• Daily wearing time of the contact lens of 8 hours or more
• Good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator.
• Subject willing to continue contact lens use for the study period
• 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 except ametropia

Exclusion Criteria:

• Participation in a clinical trial in the 3 weeks preceding the study
• Use of colored contact lenses
• Abuse of alcoholic beverages or other drugs
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12 subjects wearing soft contact lenses; The medical test device will be administered with the contact lenses inserted	Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); 1 drop of the medical device in 1 randomly chosen eye; Other: Physiological saline solution; 1 drop as placebo in the other eye not receiving the medical device
Experimental: 12 subjects wearing rigid contact lenses; The medical test device will be administered with the contact lenses inserted	Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); 1 drop of the medical device in 1 randomly chosen eye; Other: Physiological saline solution; 1 drop as placebo in the other eye not receiving the medical device
Experimental: 12 subjects with soft contact lenses; The medical test device will be administered before insertion of the contact lenses	Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); 1 drop of the medical device in 1 randomly chosen eye; Other: Physiological saline solution; 1 drop as placebo in the other eye not receiving the medical device
Experimental: 12 subjects with rigid contact lenses; The medical test device will be administered before insertion of the contact lenses	Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); 1 drop of the medical device in 1 randomly chosen eye; Other: Physiological saline solution; 1 drop as placebo in the other eye not receiving the medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Descriptive evaluation of ocular discomfort as assessed by the subjects	on 5 consecutive days before and after instillation of the eye drops

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with significant increase of redness	on 5 consecutive study days
Number of subjects experiencing adverse reactions	on 5 consecutive study days

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Croma-Pharma GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: contact lenses; safety and tolerability; Chitosan-N-Acetylcysteine
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Protective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Respiratory System Agents; Hemostatics; Coagulants; Antioxidants; Antidotes; Pharmaceutical Solutions; Chelating Agents; Sequestering Agents; Free Radical Scavengers; Expectorants; Ophthalmic Solutions; Acetylcysteine; N-monoacetylcystine; Chitosan
• Other Study ID Numbers: OPHT-290311