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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01278784

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Device: 0.05% Chitosan-N-Acetylcysteine eye drops Device: 0.1% Chitosan-N-Acetylcysteine eye drops	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Healthy volunteer

Device: 0.05% Chitosan-N-Acetylcysteine eye drops

Subjects will be randomized to receive one drop of the medical device in either the right or left eye

Device: 0.1% Chitosan-N-Acetylcysteine eye drops

Subjects will be randomized to receive one drop of the medical device in either the right or left eye

Outcome Measures

Primary Outcome Measures

Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops [6 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 less than 6 dpt
Pregnancy