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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: 0.05% Chitosan-N-Acetylcysteine eye drops
* Device: 0.1% Chitosan-N-Acetylcysteine eye drops


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteer<br> | Device: 0.05% Chitosan-N-Acetylcysteine eye drops<br>* Subjects will be randomized to receive one drop of the medical device in either the right or left eye<br>Device: 0.1% Chitosan-N-Acetylcysteine eye drops<br>* Subjects will be randomized to receive one drop of the medical device in either the right or left eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye syndromes, Chitosan-N-Acetylcysteine