Purpose: The purpose of this study was to develop an advanced in vitro blink model that can be used to examine the release of a wide variety of components (for example, topical ophthalmic drugs, comfort-inducing agents) from soft contact lenses. Methods: The model was designed using computer-aided design software and printed using a stereolithography 3D printer. The eyelid and eyeball were synthesized from polyvinyl alcohol and silicone material, respectively. Simulated tear fluid was infused through tubing attached to the eyelid using a syringe pump. With each blink cycle, the eyelid slides and flexes across the eyeball to create an artificial tear film layer. The flow-through fluid was collected using a specialized trough. Two contact lenses, etafilcon A and senofilcon A, were incubated in 2 mL of a water-soluble red dye for 24 h and then placed on the eye model (n = 3). The release of the dye was measured over 24 h using a tear flow rate of 5 µL/min. Results: Approximately 25% of the fluid that flowed over the eye model was lost due to evaporation, nonspecific absorption, and residual dead volume. Senofilcon A absorbed more dye (47.6 ± 2.7 µL) than etafilcon A (22.3 ± 2.0 µL). For etafilcon A, the release of the dye followed a burst-plateau profile in the vial but was sustained in the eye model. For senofilcon A, the release of the dye was sustained in both the vial and the eye model, though more dye was released in the vial (p < 0.05). Overall, the release of the dye from the contact lenses was higher in the vial compared with the eye model (p < 0.05). Conclusion: The blink model developed in this study could be used to measure the release of topical ophthalmic drugs or comfort agents from contact lenses. Simulation of a blink mechanism, an artificial tear film, and nonspecific absorption in an eye model may provide better results than a simple, static vial incubation model.

中文翻译：

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眼科药物递送体外眨眼模型的开发

目的：本研究的目的是开发一种先进的体外眨眼模型，该模型可用于检查软性隐形眼镜释放的各种成分（例如，局部眼科药物，诱导舒适性的物质）的释放。方法：使用计算机辅助设计软件设计模型，并使用立体光刻3D打印机进行打印。眼睑和眼球分别由聚乙烯醇和有机硅材料合成。使用注射泵通过连接到眼睑的管子注入模拟的泪液。在每个眨眼周期中，眼睑在眼球上滑动并弯曲以形成人造泪膜层。使用专用槽收集流通液。两个隐形眼镜，etafilcon A和senofilcon A，n = 3）。在24小时内使用5 µL / min的泪液流速测量了染料的释放。结果：由于蒸发，非特异性吸收和残留死体积，流经眼模型的流体约有25％损失了。Senofilcon A吸收的染料（47.6±2.7 µL）比etafilcon A（22.3±2.0 µL）多。对于etafilcon A，染料的释放遵循小瓶中的爆发-高原曲线，但在眼模型中得以维持。对于senofilcon A，尽管在小瓶中释放了更多的染料，但在小瓶和眼睛模型中染料的释放均得以维持（p <0.05）。总体而言，与眼睛模型相比，小瓶中隐形眼镜中染料的释放更高（p<0.05）。结论：本研究开发的眨眼模型可用于测量局部眼科药物或舒适剂从隐形眼镜中的释放。与简单的静态小瓶孵育模型相比，眨眼机制，人工泪膜和非特异性吸收在眼模型中的仿真可能会提供更好的结果。