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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01747616

Collaborator

Croma-Pharma GmbH (Industry)

Enrollment

Location

Arms

17.1

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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, 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 .

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) Other: Physiological saline solution	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 12 subjects wearing soft contact lenses The medical test device will be administered with the contact lenses inserted	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
Experimental: 12 subjects wearing rigid contact lenses The medical test device will be administered with the contact lenses inserted	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
Experimental: 12 subjects with soft contact lenses The medical test device will be administered before insertion of the contact lenses	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
Experimental: 12 subjects with rigid contact lenses The medical test device will be administered before insertion of the contact lenses	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

Outcome Measures

Primary Outcome Measures

Descriptive evaluation of ocular discomfort as assessed by the subjects [on 5 consecutive days before and after instillation of the eye drops]

Secondary Outcome Measures

Number of subjects with significant increase of redness [on 5 consecutive study days]
Number of subjects experiencing adverse reactions [on 5 consecutive study days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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