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

This study has been completed.
Sponsor:
Collaborator:
Croma-Pharma GmbH
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01747616
First received: December 7, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Descriptive evaluation of ocular discomfort as assessed by the subjects [ Time Frame: on 5 consecutive days before and after instillation of the eye drops ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with significant increase of redness [ Time Frame: on 5 consecutive study days ] [ Designated as safety issue: No ]
  • Number of subjects experiencing adverse reactions [ Time Frame: on 5 consecutive study days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747616

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Croma-Pharma GmbH
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01747616     History of Changes
Other Study ID Numbers: OPHT-290311
Study First Received: December 7, 2012
Last Updated: December 10, 2012
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
Chitosan-N-Acetylcysteine
contact lenses
safety and tolerability

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Acetylcysteine
N-monoacetylcystine
Tetrahydrozoline
Chitosan
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents

ClinicalTrials.gov processed this record on July 26, 2014