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

NCT ID: NCT01015209

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

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.

Detailed Description

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Conditions

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Dry Eye Syndromes

Keywords

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Dry eye syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cohort 1: 18 healthy subjects

18 healthy subjects receiving Chitosan- N- Acetylcysteine eye drops at a dose of 0.1%, 0.2% or 0.3% (6 subjects per group)

Group Type ACTIVE_COMPARATOR

Chitosan- N- Acetylcysteine eye drops

Intervention Type DEVICE

Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Cohort 2: 12 healthy patients

12 healthy subjects receiving Chitosan- N- Acetylcysteine eye drops at a dose of 0.1%, 0.2% or 0.3%

Group Type ACTIVE_COMPARATOR

Chitosan- N- Acetylcysteine eye drops

Intervention Type DEVICE

Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Interventions

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Chitosan- N- Acetylcysteine eye drops

Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. Priv.-Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT- 141009

Identifier Type: -

Identifier Source: org_study_id