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B Fuchs, C Koelwel, A Goepferich, CP Lohmann; A New Calcium-alginate Insert for Drug Delivery to the Eye: A Tolerance Study . Invest. Ophthalmol. Vis. Sci. 2002;43(13):4196.
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Purpose: For an effective pharmaceutical therapy it is necessary in some cases to maintain a constant drug level over a designed period, what can not be achieved by conventional eye drop application. For these cases, a new insert made basically out of alginates has been developed. The aim of this study was to evaluate the objective and subjective tolerance of these inserts applied to the conjunctiva. Methods: 40 healthy volunteers were devided into 4 groups and received the insert for 5 days, 3 days, 2 days or 1 day into the conjunctival cul de sac of the left eye. Prior to application, all individuals were asked for current eye-medication, the use of contact lenses and for sicca-syndrome based symptoms. The anterior segment of each eye has been examined clinically including break-up-time. 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. 5 individuals lost the insert during sleep, in all other cases the insert maintained its position under the lower eyelid. No other changes on the eye have been seen. Mild foreign body sensation was reported by all individuals within the first 30 to 60 minutes. Thereafter, no complaints were reported and the insert was well tolerated. Conclusion: Beside a mild conjunctival hyperemia, the inserts do not affect the eye. In the first few minutes, it causes discomfort, which disappears after half an hour. This study showed good insert-tolerance for ophthalmic application, so further investigations with different drugs for controled release will be the subject in the future.
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