Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Men and women aged between 18 and 45 years
- 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, ametropia < 6 dpt.
Exclusion criteria
- Participation in a clinical trial in the 3 weeks preceding the study
- Abuse of alcoholic beverages
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Ametropia of 6 or more dpt.
- Pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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