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

NCT01278784 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-12-10

No results posted yet for this study

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.

Conditions

  • Dry Eye Syndromes

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278784 on ClinicalTrials.gov