1Wiehler U., 1;2Winter M., 1Reichelt J., 3Menz D.

1Klinik für Ophthalmologie der Christian-Albrechts-Universität zu Kiel, Hegewischstr. 2, D-24105 Kiel; 2Waller Heerstraße 154a, D-28219 Bremen; 3Pharm Pur GmbH, Holzweg 27, 86156 Augsburg

Objective: A new principle for artificial tears is based on the combination of physicochemical properties of perfluorocarbons, water and fluorinated surfactants. When these components are used as polyaphrongels (PAG) a film forms on top of an aqueous phase preventing evaporation. Toxicological testings were performed for this new artificial tear formulation.
Methods: Ten different PAG were tested using the "Chicken egg test- Chorioallantois test" (HET-CAM-Test) and "bovine eye test" (BE-Test). Each PAG was tested six times on chorioallantoic membrane from incubated chicken eggs and on bovine eyes. Draize-Test was performed on nine rabbits. Each PAG was tested three times. In a long-term study three PAG were tested on nine rabbits. For two months a PAG was applied to the conjunctiva three times a day. On three rabbits the study was prolonged up to four months. Conventional artificial tears were used as reference substances in all tests.
Results: In the HET-CAM-Test and BE-Test PAG as well as reference substances caused slight irritation or no irritation. The Draize-Test and the long-term study showed no evidence of toxicity.
Conclusion: First results of the toxicity study reveal no proof against the possible use of PAG as artificial tears. *Patent-no.: DE 19938668A1

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