AVS 64th International Symposium & Exhibition
    Applied Surface Science Division Tuesday Sessions
       Session AS+TF-TuA

Invited Paper AS+TF-TuA3
Employing a Surface and Bulk Analytical Approach for the Synthesis and Characterization of Ophthalmic Biomaterials

Tuesday, October 31, 2017, 3:00 pm, Room 13

Session: Problem Solving Using Surface Analysis in the Industrial Laboratory
Presenter: Daniel Hook, Bausch + Lomb, Inc.
Authors: D. Hook, Bausch + Lomb, Inc.
A. Hoteling, Bausch + Lomb, Inc.
W. Nichols, Bausch + Lomb, Inc.
I. Nuñez, Bausch + Lomb, Inc.
K. Wygladacz, Bausch + Lomb, Inc.
Correspondent: Click to Email

Background:

During the development of a new soft contact lens material three areas of focus; regulatory requirements, manufacturing requirements and customer needs, are often used to guide the overall activities of the material development process.

Regulatory requirements are associated with material properties that are collected using methods defined by standards organizations and accepted by regulatory bodies globally. While this data is mandatory for the registration and approval of a contact lens material it is incomplete in that it only defines the basics of the material.

Manufacturing requirements such as speed of polymerization and completeness of reaction provide critical information so that an effective material can be made in a cost effective manner.

Finally, patients will demand a material that can be worn comfortably while correcting vision over the course of the wearing schedule. Patient focused parameters such as incorporation of wetting agents that create a wettable surface as well as a robust surface that will withstand handling of the course of several weeks of wear area also critical to success.

Methods:

The ISO methods 18369-4:2006, 4.6, 18369-4:2006, 4.4, 18369-4:2006, 4.5 were used to collect bulk properties of water content, oxygen permeability and refractive index while ANSI method Z80.20.2010, 7.10 was used to collect captive bubble contact angle data (CBCA). Photo-Differential Scanning Calorimetry (Photo DSC), Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography - Mass Spectrometry (LC-MS) were used to measure polymerization kinetics and monomer consumption. X-ray Photoelectron Spectroscopy (XPS) data was collected to understand surface uniformity and product consistency while Atomic Force Microscopy (AFM) was used to assess surface morphology over the course of the wearing schedule.

Results and Conclusion:

Data summarizing the submission for samfilcon A, a 46% water, 114 Dk material will be presented. CBCA coupled with XPS data will demonstrate a consistent surface wettability and chemistry across multiple lens powers and lens lots. Photo DSC, GC-MS and LC-MS will illustrate how the lens polymerizes in two distinct time resolved phases enabling the incorporation of polyvinyl pyrrolidone wetting agent into the lens bulk and surface. Together the analytical data will provide a unique picture of the data set needed for regulatory approval along with satisfying the manufacturing requirements and patient needs for a successful ophthalmic biomaterial.