A Trans-Atlantic Perspective on Stagnation in Clinical Translation of Antimicrobial Strategies for the Control of Biomaterial-Implant-Associated Infection.

Current regulatory requirements impede clinical translation and market introduction of many new antimicrobial combination implants and devices, causing unnecessary patient suffering, doctor frustration, and costs to healthcare payers. Regulatory requirements of antimicrobial combination implants and devices should be thoroughly revisited and their approval allowed based on enrichment of benefit demonstrations from high-risk patient groups and populations or device components to facilitate their clinical translation. Biomaterial implant and devices equipped with antimicrobial strategies and approved based on enrichment claims should be mandatorily enrolled in global registry studies supervised by regulatory agencies for a minimum five-year period or until statistically validated evidence for noninferiority or superiority of claims is demonstrated.

Fibrous Catalyst-Enhanced Acanthamoeba Disinfection by Hydrogen Peroxide.

Significance: Hydrogen peroxide (H2O2) disinfection systems are contact-lens-patient problem solvers. The current one-step, criterion-standard version has been widely used since the mid-1980s, without any significant improvement. This work identifies a potential next-generation, one-step H2O2, not based on the solution formulation but rather on a case-based peroxide catalyst.

1. History, evolution, and evolving standards of contact lens care.

Contact lenses and lens care regimens are an important part of eyecare practices and vital to lens-wearing patients. New contact lens materials and cleaning options continue to come to market and affect how patients wear and care for their lenses. In this section we look at how the contact lens and lens solution revolution started, how it has evolved over the last 40 years, and how standards have evolved and impacted these new offerings.

Creating antimicrobial surfaces and materials for contact lenses and lens cases.

Contact lenses are a safe and effective mode of vision correction used by more than 100 million people worldwide, yet some adverse responses to microbial contamination of contact lenses still occur. Various medical devices, including contact lens cases, currently use antimicrobial agents to eliminate or reduce microbial contamination at the surface. The application of antimicrobial surface technologies to contact lenses and lens cases is being explored.

Corneal oxygen distribution with contact lens wear.

Purpose: Since 1991, multilayer mathematical in vivo oxygenation models have been created to predict normal corneal oxygenation with contact lens wear. From these models, there have been assertions that most hydrogel contact lenses allow 97%-98% of normal corneal oxygenation compared to no contact lens wear. In light of hydrogel lens-induced neovascularization and limbal hyperemia, to clinicians, this finding seems counterintuitive.

The elution of poly (vinyl alcohol) from a contact lens: the realization of a time release moisturizing agent/artificial tear.

The use of a contact lens as a polymeric delivery vehicle is presented. Specifically, the elution of nonfunctionalized poly (vinyl alcohol) (PVA) from nelfilcon A hydrogel lenses is presented as a model of delivering polymeric active agents to the eye. High molecular weight nonfunctionalized PVA is added to the lens matrix for later release into the tears.

Clinical performance of daily disposable soft contact lenses using sustained release technology.

Purpose: Polyvinyl alcohol (PVA) is a successful tear film stabiliser and is widely used in comfort drops and some soft contact lens materials. A PVA-containing lens, nelfilcon A has been modified to include additional (non-functional) PVA in order to provide improved comfort. This study aims to examine the clinical performance of this nelfilcon A lens with AquaRelease (AquaRelease).