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M. Rotberg, C. Bosworth, A.M. Pleil, M. Zhang, D. Paggiarino; Comparison of Eyedrop Delivery Using Either a Novel Horizontal Delivery Device or a Conventional Dropper Bottle . Invest. Ophthalmol. Vis. Sci. 2006;47(13):456.
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To evaluate the ability of experienced primary open–angle glaucoma (POAG) or ocular hypertension (OHT) dropper–bottle users to safely, effectively, and bilaterally self–deliver eyedrops using either the Xalatan Ophthalmic Delivery Device (XODD) or a conventional dropper bottle.
This trial was a randomized, open–label, two–way crossover, multicenter study of 90 adult male or female subjects. The trial consisted of a Screening Visit, a Day 1 Visit, and a Day 2 Visit. Subjects were randomized to use either the XODD or a conventional dropper bottle to deliver Xalacom vehicle on the Day 1 Visit and to use the other delivery method (bottle or XODD) on the Day 2 Visit. Subjects were instructed to dose with the conventional dropper bottle as they would normally. All subjects self–administered drops in both eyes in 30–minute successions for a total of four dosing sessions. Physicians completed assessments of eyedrop delivery within three minutes of patient dosing. Patients completed tolerability assessments within five minutes of dosing.
Physician assessment indicated the XODD significantly improved subjects’ ability to successfully target both eyes with only the first drop dispensed (Table). On the fourth dosing session subjects were 1.4 times more likely to successfully administer an eyedrop with XODD than with the conventional dropper bottle. When successful delivery was defined as reaching the eye surface of both eyes irrespective of the number of drops dispensed to each eye, success was achieved for nearly every dosing session for both the XODD and the dropper bottle. Fewer treatment–related adverse events (3 versus 6, respectively) and better ocular tolerability were reported for the XODD compared to the conventional dropper bottle.
Compared to a conventional dropper bottle, the XODD significantly improved POAG and OHT subjects’ ability to self–administer medication. This finding suggests that horizontal delivery devices may improve subjects’ ability to comply with therapy. Both delivery methods were safe and well tolerated.
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