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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278784
• Other study ID #: OPHT-141010
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2010
• Last updated: December 7, 2012
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: December 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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
• 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

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops		6 weeks	No