Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2004
[Tolerance of a new calcium-alginate-insert for controlled medication therapy of the eye].
Клиническое исследованиеСравнительное исследованиеКонтролируемое клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Fuchs-Koelwel B, Koelwel C, Göpferich A, Gabler B, Wiegrebe E, Lohmann C P
Аннотация
PURPOSE: For an effective pharmaceutical treatment it is necessary in some cases to maintain a constant drug level over a certain period. This cannot be achieved by conventional eye drop application. Therefore, a new insert basically consisting of alginates with a different hydroxyethylcellulose (HEC) content was developed. The aim of this study was to evaluate the tolerance of these inserts applied to the conjunctival cul de sac.
METHODS: 24 healthy volunteers received the insert containing different concentrations of hydroxyethylcellulose (0%, 5%, 30%) for 1 up to 5 days. The eyes have been examined several times (including visual acuity, ocular surface morphology, break-up-time, Schirmer-Tear-Test). Subjective parameters were pain sensations or daily life disturbance.
RESULTS: After an initial conjunctival hyperemia and a mild foreign body sensation, the insert was well tolerated. No variations concerning the tolerance between the different concentrations of hydroxyethylcellulose were observed.
CONCLUSION: This study showed good tolerance of the new calcium-alginate-insert applied to the ocular surface for controlled drug release.
METHODS: 24 healthy volunteers received the insert containing different concentrations of hydroxyethylcellulose (0%, 5%, 30%) for 1 up to 5 days. The eyes have been examined several times (including visual acuity, ocular surface morphology, break-up-time, Schirmer-Tear-Test). Subjective parameters were pain sensations or daily life disturbance.
RESULTS: After an initial conjunctival hyperemia and a mild foreign body sensation, the insert was well tolerated. No variations concerning the tolerance between the different concentrations of hydroxyethylcellulose were observed.
CONCLUSION: This study showed good tolerance of the new calcium-alginate-insert applied to the ocular surface for controlled drug release.