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

Phase 1

Completed

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

• Registration Number: NCT01747616
• Lead Sponsor: Medical University of Vienna

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, 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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-11
• Status Verified: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 subjects wearing soft contact lenses	Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)	The medical test device will be administered with the contact lenses inserted
12 subjects with rigid contact lenses	Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)	The medical test device will be administered before insertion of the contact lenses
12 subjects wearing soft contact lenses	Physiological saline solution	The medical test device will be administered with the contact lenses inserted
12 subjects wearing rigid contact lenses	Physiological saline solution	The medical test device will be administered with the contact lenses inserted
12 subjects with soft contact lenses	Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)	The medical test device will be administered before insertion of the contact lenses
12 subjects wearing rigid contact lenses	Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)	The medical test device will be administered with the contact lenses inserted
12 subjects with soft contact lenses	Physiological saline solution	The medical test device will be administered before insertion of the contact lenses
12 subjects with rigid contact lenses	Physiological saline solution	The medical test device will be administered before insertion of the contact lenses

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of subjects experiencing adverse reactions	on 5 consecutive study days
Number of subjects with significant increase of redness	on 5 consecutive study days

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria