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Sonja Hoeller, Margit Hornof, Leopold Schmetterer, Gerhard Garhoefer; Safety And Tolerability Of Chitosan-n-acetylcysteine Eye Drops In Healthy Young Volunteers. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3841.
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To investigate the safety and tolerability of chitosan-N-acetylcysteine eye drops in different concentrations. For this purpose the safety and tolerability will be tested in two different cohorts.
In cohort I, one single instillation of the test product was performed. Chitosan-N-acetylcysteien eye drops were administered in 3 groups with ascending concentrations (0,025%, 0,05% and 0,1%), each comprising 6 healthy subjects. The medical product was instilled in one eye only, which was randomly chosen. The fellow eye served as control.. In cohort II the safety and tolerability of repeated instillation will be tested. 12 healthy subjects received the test product 2 times daily for 5 consecutive days. Evaluation criteria include visual acuity, corneal damages assessed with corneal staining, evaluation of eye redness using a grading scale based on standard photos.
In cohorte I a total number of 18 healthy volunteers were enrolled, male and female subjects were included in equal amounts. In concentration group 1 (0,025%) conjunctival redness occurred in two subjects in the study eye either right instillation of the medical product or 30 minutes after instillation, respectively. This conditions resolved 30 minutes after occurrence. In addition, one subject of concentration group 2 (0,05%) showed slight epithelial keratitis after fluoresceine staining, which was present up to 60 minutes after instillation of the product. However, given that the signs of the epithelial keratitis were present in both, the treated and the non treated eye this observation has been judged as unlikely related to the treatment. Moreover one subjects received topical medication for the treatment of the adverse event "bacterial conjunctivitis". Due to the fact that this adverse event occurred 4 days after the eye drops were instilled and that it appeared on the non treated eye, it was considered as "unlikely related". Evaluation of data of cohorte II is ongoing.
Based on the data of the single instillation in Cohort I, the tolerability and safety of Chitosan-N-Acetylcysteine eye drops showed a favourable safety profile in healthy subjects.
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