Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses

Dry Eye Syndrome Clinical Trial

Official title:

Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747616
• Other study ID #: OPHT-290311
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2012
• Last updated: December 10, 2012
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• 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, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine in subjects wearing contact lenses. This is of special interest because the tear film is critical to successful contact lens wear. Disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. This trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Regular contact lens wear since 3 years minimum

• Daily wearing time of the contact lens of 8 hours or more

• Good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator.

• Subject willing to continue contact lens use for the study period

• 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 except ametropia

Exclusion Criteria:

• Participation in a clinical trial in the 3 weeks preceding the study

• Use of colored contact lenses

• Abuse of alcoholic beverages or other drugs

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)
1 drop of the medical device in 1 randomly chosen eye

Other:
• Physiological saline solution
1 drop as placebo in the other eye not receiving the medical device

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Croma-Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive evaluation of ocular discomfort as assessed by the subjects		on 5 consecutive days before and after instillation of the eye drops	No
Secondary	Number of subjects with significant increase of redness		on 5 consecutive study days	No
Secondary	Number of subjects experiencing adverse reactions		on 5 consecutive study days	No