Joe Barr, OD, MS Brien David, MS Mohinder Merchea, OD, PhD, MBA Disclosure Statement Employment at Bausch + Lomb

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1 Joe Barr, OD, MS Brien David, MS Mohinder Merchea, OD, PhD, MBA Disclosure Statement Employment at Bausch + Lomb Presented at ISCLS 2014 in Charleston, SC May 19-23, 2014

2 Risk factors for CIEs include: Organism type Material type EW Lens modality MPS vs H202 Age MPS type? [Morgan, 2005; Chalmers, 2007; Chalmers 2007; Chalmers 2010; Chalmers, 2011; Chalmers 2012; Szczotka-Flynn, 2013; Radford, 2009]

3 Recently, (Carnt, 2009), (Sacco, 2011; Sher, 2013), (Kislan, 2010; Diec, 2009; Reeder, 2011; Zimmerman, 2012) reported CIEs and associated risk factors. Willcox 2010 found lens cases contaminated with Delftia acidovorans, Stenotrophomonas maltophilia, Serratia marcescens, and Achromobacter spp. Some organisms of patients with keratitis were identified via RNA sequencing (Wiley, 2012). Further carefully designed studies are needed if cause is to be determined.

4 Kislan TP, et al: chart review OFR used in 83.3% (45/54) who presented with acute symptomatic CIEs Diec J, et al: 3 Prospective MPS comparison 2.5 x higher incidence of significant CIEs for OFR vs AQuify among DW SiHy lens users Zimmerman AB, et al: 4 Univ. student survey 4.6 x higher event risk with any PQ-1/Aldoxbased solution vs PHMB Reeder R, et al: chart review (N=452) 44% of bilateral patients used OFR 44.7% of unilateral patients used OFR at least part time 1 Kislan TP, et al. Invest Ophthalmol Vis Sci. 2010;51: E-Abstract 3424; 2. Diec J, et al: Invest Ophthalmol Vis Sci. 2009;50:E-Abstract 5633; 3 Zimmerman AB, et al. Optom Vis Sci. 2012;89:E-abstract ; 4. Reeder R, Harthan, J. Trends Associated with corneal infiltrative events in soft lens wearers. Global Specialty Lens Symposium 2011 Annual Meeting. 5.Kilvington et al CL&AE

5 We tested the log reduction of clinical isolates from cases of CIE patients comparing 6 lens care products using a modified ISO method at 4, 6, 24 hours and 7 days.

6 ISO Standard as a guideline Three Gram negative organisms, Achromobacter xylosoxidans, Stenotrophomonas maltophilia, and Delftia Acidovirans MPS directly into polypropylene contact lens case Challenge organism inoculum ~5 x 105 colony forming units(cfu)/ml Testing was performed at 4 hours, 6 hours, 24 hours and Day 7 after inoculation. Three lots of each MPS were tested on three different days

7 Three of the solutions showed >3 log reduction (>99.9%) for each of the organisms at all time points. Three solutions did not reach this level. Log reductions ranged from >5.0 to log reduction of -0.9 log.

11 *Grew in the solution over 14 days Efficacy of MPS was assessed against bacteria from CL storage cases cultured from 18 patients with CIEs No controls MPS log reductions range from <1 to > 4 for Achromobacter, S maltophilia, Delftia spp 11 had Achromobactor spp, 4Stenotrophomonas maltophilia, 3 Serratia marcescens, 3 Delftia spp*, and 2 Elizabethkingia spp 2 Chryseobacterium indologenes and 1 Sphingobacterium spiritivorum. All Achromobactoer strains resistant to the solution with < 1 log kill after 14 days exposure Hypothesis - endotoxin lipopolysaccharides from bacterial outer membranes may induce immunologic corneal response

12 Retrospective, masked, MC case-control study Specific aim: To identify risk factors for acute, symptomatic CIEs relative to lens and lens care product usage Chalmers R, et al. Optom Vis Sci. 2012;89:

13 Cases of CIEs defined to identify associations with a lens care solution Case definitions included CLARE, SEAL, Viral keratoconjunctivitis, MK, CLPU, Daily disposable or EW patients Chalmers R, et al. Optom Vis Sci. 2012;89:

15 27% of cases could not specify which product but adjusted for market share 5% of cases could not identify any lens care solution which is always difficult To detect a 50% increased odds of a CIE comparing one MPS to all other MPS (at an 80% power level) would require about 263 cases and 789 controls Chalmers R, et al. Optom Vis Sci. 2012;89:

16 In vitro MPS testing can lead to a basis for further study design Lens material, lens modality, lens care products and compliance may be amongst the many factors associated with CIEs. Case series and even well done case-control studies are limited and require focused eligibility and exclusion criteria, and large sample sizes. Randomized, controlled trials would be prohibitively complex and expensive for studying CIEs associated with lens care solutions. Lens care compliance remains a major issue and attempts to improve compliance are underway by CDC and others

17 Bioburden is a well-known risk factor for CIEs 1 Case contamination with gram-negative clinical isolates has been repeatedly demonstrated 2,3 SiHy lenses may serve as vector, transferring gramnegative bacteria or endotoxins from contaminated cases to the eye 4 Further research is warranted to understand if a gramnegative bioburden may increase the risk for CIEs 1. Szczotka-Fkynn L, et al. Eye Contact Lens. 2013;39:49-52; 2. Willcox MDP, et al. Optometry Vis Sci. 2010;87: ; 3. Kilvington S, et al. Invest Ophthalmol Vis Sci. 2012;53:E-Abstract 1033; 4. Vijay AK, et al. Presented at the 2013 ARVO Annual Meeting; May 5, 2013; Seattle, WA. Abstract 506.

A Compendium of Clinical and Laboratory Studies Multi-Purpose Disinfecting Solutions (MPDS)

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