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| Name | Class |
|---|---|
| Croma-Pharma GmbH | INDUSTRY |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 subjects wearing soft contact lenses | Experimental | The medical test device will be administered with the contact lenses inserted |
|
| 12 subjects wearing rigid contact lenses | Experimental | The medical test device will be administered with the contact lenses inserted |
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| 12 subjects with soft contact lenses | Experimental | The medical test device will be administered before insertion of the contact lenses |
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| 12 subjects with rigid contact lenses | Experimental | The medical test device will be administered before insertion of the contact lenses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) | Device | 1 drop of the medical device in 1 randomly chosen eye |
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| Measure | Description | Time Frame |
|---|---|---|
| Descriptive evaluation of ocular discomfort as assessed by the subjects | on 5 consecutive days before and after instillation of the eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with significant increase of redness | on 5 consecutive study days | |
| Number of subjects experiencing adverse reactions | on 5 consecutive study days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
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| Physiological saline solution | Other | 1 drop as placebo in the other eye not receiving the medical device |
|
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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