TetraScience (United States)

*Korb Associates, Boston, MA †TearScience Inc, Morrisville, NC Financial disclosures/conflicts of interest: None reported. Supported by Korb Associates, Boston, MA; TearScience Inc, Morrisville, NC.

To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort. LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events. The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.

Abstract The CellCard system provides a novel platform for cell‐based assays. At the core of the platform are encoded particles referred to as CellCards. By growing individual cell types on CellCards with unique codes, the platform enables multiple cell types to be assayed simultaneously in 96‐well format. This article describes the CellCard technology and how it can be applied to the determination of cell‐type selectivity of bioactive molecules.

The CellCard system enables the analysis of multiple cell types within a single microtiter well. In doing so, the CellCard system not only determines the effect of an experimental condition on a cell type of interest, but also the relative selectivity of that response across nine other cell types. In addition, this approach of cellular multiplexing is a means of miniaturization without the necessity of microfluidic devices. The standard 96-well plate generates ten 96-well plates of data (or, the equivalent of a 960-well plate). Taken together, the CellCard technology enables multiple cell types to be assayed within a single microtiter well allowing for the simultaneous determination of cellular activity and compound selectivity. This chapter will describe a method by which multiple cell types can be simultaneously assayed for biological parameters of interest.

Image cytometry has made possible the collection and analysis of multiparameter cellular information. The wider use of image cytometry in drug screening will depend on its throughput, efficiency, repeatability, and on the added benefits compared with less sophisticated but faster methods. Throughput (number of datapoints per unit of time) and efficiency (number of datapoints from the given amount of reagents or plate area) are addressed here by screening multiple cell lines simultaneously using encoded carriers (CellCards). CellCards are rectangular particles with an expandable color barcode and a transparent section for cellular readout. Before performing the assay, each cell line is grown on a different class of carriers. CellCards, with attached cells, are mixed and dispensed into a microtiter plate where the assay is performed. Next the plates are imaged, decoded and the cells associated with each CellCard class are analyzed. Using CellCards the efficiency is increased by the multiplexing factor (the number of cell lines analyzed in each well). We routinely run assays with a multiplex factor of ten. Throughput is additionally addressed by working at the lowest possible magnification for a given assay. Decoding of CellCards requires one image per well in 96-well microtiter plate format. The system provides the added benefit of internal consistency since the data can be normalized to controls within each well.