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Tolerance of a New Calcium-alginate-insert for Drug Delivery to the Eye
1Fuchs B., 2Kölwl C., 2Göpferich A., 1Gabler B., 1Lohmann C.,
1Universität Regensburg, Klinik und Poliklinik für Augenheilkunde (Regensburg)
2Universität Regensburg, Institut für Pharmazeutische Technologie (Regensburg)
Purpose: For an effective pharmaceutical therapy of different diseases of the eye surface it is necessary to maintain a constant drug level over a designed period, what often can not be achieved by conventional eye drop application. For these cases, a new insert for controlled release has been developed. It is basically made out of alginates and different concentrations of hydroxyethylcellulose (HEC). The aim of this study was to evaluate the objective and subjective tolerance of these inserts applied to the conjunctiva.
Methods: 24 healthy volunteers were devided into 4 groups and received the insert for 5, 3, 2 or 1 day after asking for patients history and after clinical examination. 2 individuals of each group received an insert without HEC, 2 with 5% HEC and 2 with 30% HEC. After application of the insert, the eyes have been examined immediately, after 8 hours and then each day until removal of the insert. Every individual had to fill out a scale for subjective pain and for daily life disturbance.
Results: After application, all eyes showed minimal conjunctival hyperemia for the first 5 to 15 minutes. 3 individuals lost the insert during sleep. Mild foreign body sensation was reported by all individuals within the first 30 to 60 minutes. Thereafter, the insert was well tolerated. Nor subjective nor objective clinical differences have been seen between the different concentrations of HEC.
Conclusions: This study showed good insert-tolerance for ophthalmologic application, so further investigations with different drugs for controlled release will be the subject in the future.