Safety and 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.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: 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 of 6 or more 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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohort 1: 18 healthy subjects<br>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<br>* Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days<br>|
| Active Comparator: Cohort 2: 12 healthy patients<br>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<br>* Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye syndromes