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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01015209

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Device: Chitosan- N- Acetylcysteine eye drops	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Device: Chitosan- N- Acetylcysteine eye drops Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days
Active Comparator: 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%	Device: Chitosan- N- Acetylcysteine eye drops Cohort 1: 1 drop once Cohort 2: 2 drops daily for 5 days

Arm

Intervention/Treatment

Active Comparator: 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)

Device: Chitosan- N- Acetylcysteine eye drops

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

Active Comparator: 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%

Device: Chitosan- N- Acetylcysteine eye drops

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

Outcome Measures

Primary Outcome Measures

Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops [5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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