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Damien F. Goldberg, Robert Williams; A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG). Invest. Ophthalmol. Vis. Sci. 2012;53(14):5095.
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To evaluate the safety and efficacy of the Latanoprost Punctal Plug Delivery System (L-PPDS) in subjects with Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Approximately 95 subjects had 4 weeks of treatment with simultaneous bilateral L-PPDS placement in both the upper and lower puncta. The trial used a proprietary punctal plug in the lower punctum and an early stage prototype punctal plug based on a modified commercially available plug in the upper puncta, with a combined latanoprost amount of 141 µg. Subjects were followed up for assessment of safety and intraocular pressure (IOP) effect. Analysis of IOP effect was based on change from baseline. Adverse events (AEs) and adverse device events (ADEs) were monitored.
After 4 weeks of L-PPDS treatment, mean IOP change from baseline was statistically significant at -5.7 mmHg (95% C.I. -6.5, -4.9). 60% of subjects showed an IOP reduction vs. baseline of 5 mmHg or greater and 47% of subjects showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at 4 weeks was also statistically significant at 22.3% (95% C.I. -25.4, -19.2). The L-PPDS was well tolerated over the testing period with adverse events (AEs) similar to those reported for commercial punctal plugs. The majority of AEs were ocular, with tearing reported as the most frequent. No associated AEs were serious. Few subjects experienced any discomfort related to the punctal plugs with most patients having either no awareness or mild awareness of the punctal plugs by week 4 (87% of eyes for L-PPDS subjects).
This is the first reported demonstration of a clinically significant, prolonged (4 weeks) reduction in intraocular pressure (IOP) in glaucoma with an extraocular, minimally-invasive sustained release ophthalmic drug delivery system. These results have significant implications for maintaining compliance for patients.
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