Qualitative and quantitative characterization of the in vitro dehydration process of hydrogel contact lenses

PURPOSE: To investigate the in vitro dehydration process of conventional hydrogel and silicone-hydrogel contact lens materials. METHODS: Eight conventional hydrogel and five silicone-hydrogel contact lenses were dehydrated under controlled environmental conditions on an analytical balance. Data were taken at 1-min intervals and dehydration curves of cumulative dehydration (CD), valid dehydration (VD), and dehydration rate (DR) were obtained. Several quantitative descriptors of the dehydration process were obtained by further processing of the information. RESULTS: Duration of phase I (r(2) = 0.921), CD at end of phase I (r(2) = 0.971), time to achieve a DR of -1%/min (r(2) = 0.946) were strongly correlated with equilibrium water content (EWC) of the materials. For each individual sample, the VD at different time intervals can be accurately determined using a 2nd order regression equation (r(2) > 0.99 for all samples). The first 5 min of the dehydration process show a relatively uniform average CD of about -1.5%/min. After that, there was a trend towards higher average CD for the following 15 min as the EWC of the material increases (r(2) = 0.701). As a consequence, average VD for the first 5 min displayed a negative correlation with EWC (r(2) = 0.835), and a trend towards uniformization among CL materials for the following periods (r(2) = 0.014). Overall, silicone-hydrogel materials display a lower dehydration, but this seems to be primarily due to their lower EWC. CONCLUSIONS: DR curves under the conditions of the present study can be described as a three-phase process. Phase I consists of a relatively uniform DR with a duration that ranges from 10 to almost 60 min and is strongly correlated with the EWC of the polymer as it is the CD during this phase. Overall, HEMA-based hydrogels dehydrate to a greater extent and faster than silicone-hydrogel materials. There are differences in water retention between lenses of similar water content and thickness that should be further investigated

Stretchable electronic platform for soft and smart contact lens applications

A stretchable platform with spherical-shaped electronics based on thermo- plastic polyurethane (TPU) is introduced for soft smart contact lenses. The low glass transition temperature of TPU, its relatively low hardness, and its proven biocompatibility (i.e., protection of exterior body wounds) fulfill the essential requirements for eye wearable devices. These requirements include optical transparency, conformal fitting, and flexibility comparable with soft contact lenses (e.g., hydrogel-based). Moreover, the viscoelastic nature of TPU allows planar structures to be thermoformed into spherical caps with a well-defined curvature (i.e., eye’s curvature at the cornea: 9 mm). Numerical modeling and experimental validation enable fine-tuning of the thermo - forming parameters and the optimization of strain-release patterns. Such tight control is proven necessary to achieve oxygen permeable, thin, nonde- velopable, and wrinkle-free contact lenses with integrated electronics (silicon die, radio-frequency antenna, and stretchable thin-film interconnections). This work paves the way toward fully autonomous smart contact lenses potentially for vision correction or sensing applications, among others

Equivalences between refractive index and equilibrium water content of conventional and silicone hydrogel soft contact lenses from automated and manual refractometry

PURPOSE: The purpose of the present study was to develop mathematical relationships that allow obtaining equilibrium water content and refractive index of conventional and silicone hydrogel soft contact lenses from refractive index measures obtained with automated refractometry or equilibrium water content measures derived from manual refractometry, respectively. METHODS: Twelve HEMA-based hydrogels of different hydration and four siloxane-based polymers were assayed. A manual refractometer and a digital refractometer were used. Polynomial models obtained from the sucrose curves of equilibrium water content against refractive index and vice-versa were used either considering the whole range of sucrose concentrations (16-100% equilibrium water content) or a range confined to the equilibrium water content of current soft contact lenses ( approximately 20-80% equilibrium water content). RESULTS: Values of equilibrium water content measured with the Atago N-2E and those derived from the refractive index measurement with CLR 12-70 by the applications of sucrose-based models displayed a strong linear correlation (r(2) = 0.978). The same correlations were obtained when the models are applied to obtain refractive index values from the Atago N-2E and compared with those (values) given by the CLR 12-70 (r(2) = 0.978). No significantly different results are obtained between models derived from the whole range of the sucrose solution or the model limited to the normal range of soft contact lens hydration. CONCLUSIONS: Present results will have implications for future experimental and clinical research regarding normal hydration and dehydration experiments with hydrogel polymers, and particularly in the field of contact lenses.This study was supported in part by a grant from the Science and Technology Foundation (FCT) - Ministry of Science and Superior Education (MCES) under contract 8281/2002 from the European Social Funding granted to JMG-M

The preparation of HEMA-MPC films for ocular drug delivery

There is a need to prolong drug residence time using a biocompatible formulation in the subconjunctival space after surgery to treat glaucoma. Drug releasing discs were prepared with 2-(hydroxyethyl)methacrylate (HEMA) and 2-methacryloyl-oxyethyl phosphorylcholine (MPC). The ratio of bound water (Wb) to free water (Wf) ratio increased from 1:0.3 to 1:6.8 with increasing MPC (0 to 50%, w/w). The optimal balance between water content, SR and mechanical strength were obtained with 10% MPC (w/w) hydrogels. Water-alcohol mixtures were examined to facilitate loading of poorly soluble drugs, and they showed greater hydrogel swelling than either water or alcohol alone. The SR was 1.2 ± 0.02 and 3.3 ± 0.1 for water and water:ethanol (1:1) respectively. HEMA-MPC (10%) discs were loaded with dexamethasone using either water:ethanol (1:1) or methanol alone. Drug release was examined in an outflow rig model that mimics the subconjunctival space in the eye. Dexamethasone loading increased from 0.3 to 1.9 mg/disc when the solvent was changed from water:ethanol (1:1) to methanol with the dexamethasone half-life (t½) increasing from 1.9 to 9.7 days respectively. These encouraging results indicate that HEMA-MPC hydrogels have the potential to sustain the residence time of a drug in the subconjunctival space of the eye

Development and evaluation of performance characteristics of timolol-loaded composite ocular films as potential delivery platform for treatment of glaucoma

Thin and erodible polymeric films were developed as potential ocular drug delivery systems to increase drug retention on the eye with the aim of improving bioavailability and achieving controlled drug release. Two biocompatible film forming polymers, hyaluronic acid (HA) and hydroxypropyl methylcellulose (HPMC), which are currently used as thickening agents in eye drops were employed. Two different films were prepared (i) as single polymer and (ii) as composite formulations by solvent casting method, incorporating glycerol (GLY) as plasticizer and timolol maleate (TM) as model glaucoma drug. After preliminary optimization of transparency and ease of handling, the formulations were further characterized for their physicochemical properties. No indication of significant drug-polymer or polymer-polymer (in composite films) interaction was observed from FTIR results while evaluation by IR mapping revealed uniform distribution of drug throughout the films. Amorphization of TM in the film matrix was confirmed by both DSC and XRD. Swelling studies illustrated remarkable swelling capacity of HA in comparison with HPMC which directly affected the drug release profiles, making HA a suitable polymer for controlled ocular drug delivery. Tensile and mucoadhesion properties confirmed higher elasticity and adhesiveness of HA while HPMC produced stronger films. The effect of sterilization by UV radiation on mechanical properties was also evaluated and showed no significant difference between the sterilized and non-sterilized films. The SEM results confirmed smoothness and homogeneity of film surfaces for all the formulations studied. The in vitro drug dissolution studies showed more extended release profiles of formulations containing HA. Cytotoxicity study (cell viability) using MTT assay on HeLa cells, confirmed that the single polymer and composite films are generally safe for ocular administration. The present work shows excellent film forming ability of HA and HPMC which can be used as single polymer or combined in composite formulations as potential topical ocular drug delivery platform to enhance drug retention on the ocular surface and therefore potential improved bioavailability

The Effect of Fractal Contact Lenses on Peripheral Refraction in Myopic Model Eyes

Purpose: To test multizone contact lenses in model eyes: Fractal Contact Lenses (FCLs), designed to induce myopic peripheral refractive error (PRE). Methods: Zemax ray-tracing software was employed to simulate myopic and accommodation-dependent model eyes fitted with FCLs. PRE, defined in terms of mean sphere M and 90–180 astigmatism J180, was computed at different peripheral positions, ranging from 0 to 35 in steps of 5, and for different pupil diameters (PDs). Simulated visual performance and changes in the PRE were also analyzed for contact lens decentration and model eye accommodation. For comparison purposes, the same simulations were performed with another commercially available contact lens designed for the same intended use: the Dual Focus (DF). Results: PRE was greater with FCL than with DF when both designs were tested for a 3.5 mm PD, and with and without decentration of the lenses. However, PRE depended on PD with both multizone lenses, with a remarkable reduction of the myopic relative effect for a PD of 5.5 mm. The myopic PRE with contact lenses decreased as the myopic refractive error increased, but this could be compensated by increasing the power of treatment zones. A peripheral myopic shift was also induced by the FCLs in the accommodated model eye. In regard to visual performance, a myopia under-correction with reference to the circle of least confusion was obtained in all cases for a 5.5 mm PD. The ghost images, generated by treatment zones of FCL, were dimmer than the ones produced with DF lens of the same power. Conclusions: FCLs produce a peripheral myopic defocus without compromising central vision in photopic conditions. FCLs have several design parameters that can be varied to obtain optimum results: lens diameter, number of zones, addition and asphericity; resulting in a very promising customized lens for the treatment of myopia progression.This research was supported by the Ministerio de Economia y Competitividad (grant FIS2011-23175), the Generalitat Valenciana (grant PROMETEO2009-077) and the Universitat Politecnica de Valencia (grant INNOVA SP20120569), Spain.Rodríguez Vallejo, M.; Benlloch Fornés, JI.; Pons Martí, A.; Monsoriu Serra, JA.; Furlan, WD. (2014). The Effect of Fractal Contact Lenses on Peripheral Refraction in Myopic Model Eyes. Current Eye Research. 39(12):1-10. https://doi.org/10.3109/02713683.2014.903498S110391