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

NCT01278784 | Completed Phase 1 DMC

• 1 other identifier: OPHT-141010
• Study Type: interventional
• Target: 24
• 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. 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

Keywords

Dry eye syndromes; Chitosan-N-Acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops

  6 weeks

Study Arms (1)

Healthy volunteer

EXPERIMENTAL

Device: 0.05% Chitosan-N-Acetylcysteine eye drops; Device: 0.1% Chitosan-N-Acetylcysteine eye drops

Interventions

0.05% Chitosan-N-Acetylcysteine eye drops DEVICE

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

Healthy volunteer

0.1% Chitosan-N-Acetylcysteine eye drops DEVICE

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

Healthy volunteer

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 less than 6 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: January 19, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

AU (1)