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

NCT01015209 | Completed Phase 1 DMC

• 1 other identifier: OPHT- 141009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Dry eye syndromes

Outcome Measures

Primary Outcomes (1)

• Difference between the treated and the non- treated eye with Chitosan- N- Acetylcysteine eye drops

  5 weeks

Study Arms (2)

Cohort 1: 18 healthy subjects

ACTIVE COMPARATOR

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 2: 12 healthy patients

ACTIVE COMPARATOR

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

Interventions

Chitosan- N- Acetylcysteine eye drops DEVICE

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

Cohort 1: 18 healthy subjects; Cohort 2: 12 healthy patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

AU (1)