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

NCT01747616 | Completed Phase 1 DMC

• 1 other identifier: OPHT-290311
• Study Type: interventional
• Target: 48
• 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, 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 .

Conditions

Dry Eye Syndrome

Keywords

Chitosan-N-Acetylcysteine; contact lenses; safety and tolerability

Outcome Measures

Primary Outcomes (1)

• Descriptive evaluation of ocular discomfort as assessed by the subjects

  on 5 consecutive days before and after instillation of the eye drops

Secondary Outcomes (2)

• Number of subjects with significant increase of redness

  on 5 consecutive study days

• Number of subjects experiencing adverse reactions

  on 5 consecutive study days

Study Arms (4)

12 subjects wearing soft contact lenses

EXPERIMENTAL

The medical test device will be administered with the contact lenses inserted

Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution

12 subjects wearing rigid contact lenses

EXPERIMENTAL

The medical test device will be administered with the contact lenses inserted

Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution

12 subjects with soft contact lenses

EXPERIMENTAL

The medical test device will be administered before insertion of the contact lenses

Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution

12 subjects with rigid contact lenses

EXPERIMENTAL

The medical test device will be administered before insertion of the contact lenses

Device: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%); Other: Physiological saline solution

Interventions

Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) DEVICE

1 drop of the medical device in 1 randomly chosen eye

12 subjects wearing rigid contact lenses; 12 subjects wearing soft contact lenses; 12 subjects with rigid contact lenses; 12 subjects with soft contact lenses

Physiological saline solution OTHER

1 drop as placebo in the other eye not receiving the medical device

12 subjects wearing rigid contact lenses; 12 subjects wearing soft contact lenses; 12 subjects with rigid contact lenses; 12 subjects with soft contact lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Croma-Pharma GmbH: collaborator

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

AU (1)