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

NCT ID: NCT01015209

Last Updated: 2012-09-25

Basic Information

• 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

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Chitosan- N- Acetylcysteine eye drops

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

Intervention Type: DEVICE

Eligibility Criteria

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

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. Priv.-Doz. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

OPHT- 141009

Identifier Type: -

Identifier Source: org_study_id