Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating
Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular
membrane and vitrectomy.
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
The purpose of this study is to determine the safety and efficacy of Next Generation
Ophthalmic Irrigating Solution (NGOIS) compared to BSS Plus for use during cataract
extraction and intra-ocular lens (IOL) implantation.
Concentration of Itraconazole Solution in Nasal Secretions
The primary objective of this study is to determine the concentration of itraconazole
irrigation in nasal mucous specimens via collection and High-performance liquid
chromatography (HPLC) assay.
Eight (8) patients with chronic rhinosinusitis (CRS) and two (2) healthy controls will be
enrolled in the initial evaluation. After an initial control nasal specimen, followed by
seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected
at varying time intervals and the concentrations measured.
The primary endpoint is development of a reliable collection and assay technique with
concentration curves over time of topically administered itraconazole. A secondary endpoint
is to determine if the concentrations measured achieve a mean inhibitory concentration
(MIC90) to commonly cultured fungal species in the nose.
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