A soft contact-lens biosensor (SCL-biosensor) for novel non-invasive biomonitoring of tear fluids was fabricated and tested. Wearing a biosensor on eye enabled the in situ monitoring of tear contents. The biosensor has an enzyme immobilized electrode on the surface of a polydimethyl siloxane (PDMS) contact lens. The SCL-biosensor was fabricated using microfabrication techniques for functional polymers (PDMS and 2-methacryloyloxyethyl phosphorylcholine (MPC) polymer). In investigation of in vitro characterization, the SCL-biosensor showed excellent relationship between the output current and glucose concentration from 0.03 to 5.0 mmol·L(-1), with a correlation coefficient of 0.994. The calibration range covered the reported tear glucose concentrations (0.14 mmol·L(-1)). Based on the result, ocular biomonitoring with the SCL-biosensor was carried out. The SCL-biosensor well worked both in the static state and the dynamic state. The tear glucose level of rabbit was estimated to 0.12 mmol·L(-1) at first and then the tear turnover was successfully calculated to be 29.6 ± 8.42% min(-1). The result indicated that SCL-biosensor is useful for advanced biomonitoring on eye.

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A wearable amperometric glucose sensor was fabricated and tested. Also, the sensor was utilized to tear glucose monitoring. The sensor was constructed by immobilizing GOD onto a flexible oxygen electrode, which was fabricated using "Soft-MEMS" techniques onto a functional polymer membrane. In purpose of bioinstrumentation, adhesive agents were not used for constructing the flexible biosensor. Linear relationship between glucose concentration and output current was obtained in a range of 0.039 -0.537 mmol/l. Current dependences on pH and temperature were also evaluated. The current was largest at pH 7.0 and the current increased when temperature increased. This indicates that the output current depends on enzyme activity. Based on the basic characteristics investigation, the glucose sensor was applied to measurement of glucose in tear fluids on an eye site of a Japan white rabbit. The change of tear glucose level induced by oral-administration of glucose was monitored as a current change of the sensor attached on the eye site. In this investigation, the tear glucose level varied from 0.2 mmol/l to 0.5 mmol/l. Although there was a delay of several tens of minutes towards blood sugar level, it is considered to be possible that non-invasive continuous glucose monitoring can be realized using the flexible biosensor.

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