[Tolerance of a new calcium-alginate-insert for controlled medication therapy of the eye].
OBJECTIVE
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.


CONCLUSIONS
This study showed good tolerance of the new calcium-alginate-insert applied to the ocular surface for controlled drug release.
Fuchs-Koelwel
B
B
Universitätsaugenklinik Regensburg. Fuchs@eye-regensburg.de
Koelwel
C
C
Göpferich
A
A
Gabler
B
B
Wiegrebe
E
E
Lohmann
C P
CP
D000464:Alginates; D001672:Biocompatible Materials / Q000737:chemistry; D004337:Drug Carriers / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D016503:Drug Delivery Systems / Q000009:adverse effects* / Q000379:methods*; D004343:Drug Implants / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D005128:Eye Diseases / Q000175:diagnosis / Q000209:etiology*; D005549:Foreign-Body Reaction / Q000175:diagnosis / Q000209:etiology*; D020723:Glucuronic Acid; D006603:Hexuronic Acids; D006801:Humans; D008422:Materials Testing; D009883:Ophthalmic Solutions / Q000008:administration & dosage*
D000464:Alginates; D001672:Biocompatible Materials; D004337:Drug Carriers; D004343:Drug Implants; D006603:Hexuronic Acids; D009883:Ophthalmic Solutions; D020723:Glucuronic Acid