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

A Compendium of Clinical and Laboratory Studies Multi-Purpose Disinfecting Solutions () Contact Lens Case Contamination Disinfection and FDA/ISO Standards Disinfection and Clinical Isolates Acanthamoeba Efficacy Cytotoxicity Corneal Staining Adverse Events, Including Corneal Infiltrates Lens Compatibility, Cleanliness and Comfort RL-Compendium-Rebuild.indd // :8 AM

Contact Lens Case Contamination During Daily Wear of Silicone Hydrogels Mark D. P. Willcox, PhD; Nicole Carnt, BOptom; Jennie Diec, BOptom; Thomas Naduvilath, PhD; Vicki Evans, PhD; Fiona Stapleton, PhD, FAAO; Shamil Iskandar, BSc; Najat Harmis BSc; Percy Lazon de la Jara, PhD; and Brien A. Holden, PhD, DSc, FAAO; Sydney, Australia Incidence of lens case contamination with Delftia acidovorans and Stenotrophomonas maltophilia is high with. Stenotrophomonas maltophilia was formerly classified as a pseudomonas species. Both are commonly found in tap water, where they are food sources for Acanthamoeba.,, Objective: This study aimed to evaluate the contamination rate and types of microbes contaminating cases during use of contact lens disinfecting solutions and silicone hydrogel lenses. Contamination of contact lens cases has been associated with the production of adverse responses in the eye during contact lens wear. Method: participants were allocated to one or more groups. The participants wore one or more of three silicone hydrogel lenses and used one or more of four contact lens disinfecting solutions. Cases were collected after use for month and sent for routine microbial testing. The rate of contamination of cases and the types of microbes contaminating cases were evaluated. Participants were all instructed to use the cases for month, return the case to the clinic (or dispose of the case). As each participant had scheduled visits at month and months of lens wear, two lens cases were collected for each lens/solution combination for each participant. Solutions: AQuify MPS, Clear Care System, Express, Lenses: ACUVUE OASYS (Senofilcon A), Biofinity (Comfilcon A), PureVision (Balafilcon A) Participants: Lenses were worn on a daily basis for months by participants. Approximately participants were enrolled for each lens/solution combination (ACUVUE OASYS / Clear Care System; PureVision /AQuify MPS; Biofinity /Clear Care System; Biofinity /AQuify MPS; Biofinity / Express ; and Biofinity / ). Incidence of lens case contamination with Delftia acidovorans and Stenotrophomonas maltophilia is high with. Different disinfecting solutions used during storage in cases result in different levels of contamination and contamination by different types of microbes. These differences are not simply because of the types of disinfectants used, suggesting that other excipients in, or formulation of, the solution affect contact lens storage case contamination. Peer-reviewed article from Optometry and Vision Science, Vol. 8, No., July. Denton M, Kerr KG. Microbiological and Clinical Aspects of Infection Associated with Stenotrophomonas maltophilia. Clinical Microbiology Reviews, Vol.. No.. p. -8, Jan. 998. Leeds, United Kingdom.. Willcox M, Hume BH. Emergence of Serratia marcescens as an Ocular Surface Pathogen. Archive of the Spanish Society of Ophthalmology, Vol. 9, No., Oct.. Madrid, Spain.. Lee SM, Kim MK, Lee JL, Wee WR, Lee JH. Experience of Comamonas acidovorans keratitis with Delayed Onset and Treatment Response in Immunocompromised Cornea. Korean Journal of Ophthalmology, Vol., No., p. 9-, 8. Taejon, Korea.. Wang X, Ahearn D. Effect of Bacteria on Survival and Growth of v castellanii. Current Microbilology, Vol., No., p. -, April 99. Atlanta, GA. Percentage cases contaminated Percentage cases contaminated (%) Delftia acidovorans Stenotrophomonas maltophilia Clear Care System Delftia acidovorans Serratia marcescens Stenotrophomonas maltophilia Achromobacter Group A Express AQuify MPS RL-Compendium-Rebuild.indd - // :8 AM

Antimicrobial Properties of a New Multi-Purpose Contact Lens Disinfectant Solution Simon Kilvington, PhD; Charles Powell, MS; Anthony Lam, BS; Marina Nikolic, BS; Nancy Brady, BS; Santa Ana, CA, USA (a solution containing the unique dual disinfectants polyquaternium- and alexidine dihydrochloride) was formulated with broad-spectrum disinfection to meet the challenges posed by emerging pathogens and patient noncompliance. Background: Keratitis (corneal infection) can result in permanent blindness and occurs with greater frequency in CL wearers. Two keratitis outbreaks affecting contact lens wearers in recent years were caused by the mold Fusarium and the amoeba Acanthamoeba. As a result, the microbiological efficacy of MPS products has fallen under intense scrutiny. Therefore, MPS products and current test methods should be evaluated to meet the challenges posed by emerging pathogens, user noncompliance, and newer, more complex product formulations. Method: Biocidal assays were performed according to ISO 9 using automated serial dilution equipment. Acanthamoeba viability was determined using the same automated serial dilution equipment. and were tested against clinical isolates of bacteria and fungi. Solutions were also compared for biocidal efficacy against Acanthamoeba castellanii when tested in the presence of various contact lens materials and in the solution manufacturer s recommended lens storage case. Solution brand Biotrue MPS Clear Care System Disinfectant agents polyquaternium- + alexidine PHMB and polyquaternium PQ- + Aldox Hydrogen peroxide (%) + platinum neutralizing disk Lenses: NIGHT & DAY (Lotrafilcon A), SofLens 8 (Polymacon), PureVision (Balafilcon A), ACUVUE (Etafilcon A) exceeds ISO requirements for microbial efficacy (>9.99-99.99% kill of bacteria and fungi). Efficacy of CL care solutions against ISO bacteria Bacteria log reduction Ps. aeruginosa S. marcescens S. aureus Solution brand hr hr hr hr hr hr >. >. >. >. >. >. Biotrue MPS >. >. >. >.. >. >. >...8.. Clear Care System >. >. >. >. >. >. ISO 9 requires a minimum of log (99.99%) kill for bacteria at the manufacturer s recommended soaking time ( to hours). Efficacy of CL care solutions against ISO fungi Fungal log reduction Candida albicans Fusarium solani Solution brand hr hr hr hr >. >..9 >. Biotrue MPS >. >. >. >....8. Clear Care System >. >..9.9 ISO 9 requires a minimum of log (9%) kill of fungi at the manufacturer s recommended soaking time ( to hours). is highly effective (>99.9%) against Acanthamoeba trophozoites and resistant cyst stage vs. and Biotrue MPS. Effi cacy of CL care solutions against Acanthamoeba Acanthamoeba castellanii log reduction Trophozoites Cysts Solution brand hr hr hr hr >. >. >. >. Biotrue MPS >. >....... Clear Care System >. >... is 99.99% effective against resistant clinical microbes including Staphylococcus aureus MRSA, Pseudomonas aeruginosa, Candida albicans, Fusarium solani, and Stenotrophomonas maltophilia. Ocutec is a contact lens based on the unique dual disinfectants of polyquaternium- and alexidine dihydrochloride. Ocutec : Exceeds ISO requirements for microbial effi cacy (>9.99 99.99 % kill of bacteria and fungi). Highly effective (>99.9%) against Acanthamoeba trophozoites and resistant cyst stage. >99.99% effective against resistant clinical microbes such as Staphylococcus aureus MRSA. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. and Journal of Optometry, ():-, July. RL-Compendium-Rebuild.indd - // :8 AM

Evaluation of Antimicrobial Efficacy of Multi-Purpose Solutions against Clinical Microbial Isolates Hua Zhu, PhD; Rani Bandara, BSc; Simin Masoudi, BSc; Duojia Wu, MSc; Mark D.P. Willcox, PhD; Brien Holden Vision Institute, Sydney, Australia There are two organisms that are uncommonly found in contact lens cases - Acanthamoeba and Fusarium. This study shows that (a solution containing the disinfectants polyquaternium- and alexidine dihydrochloride) is very effective in destroying these organisms and that a solution containing the disinfectants polyquaternium- and Aldox ( ) was less effective. Objective: Evaluate the antimicrobial efficacy of two Multi-Purpose Solutions against ISO panel organisms and clinical isolates. Method: The antimicrobial activity of lens care products against bacterial and fungal isolates was evaluated in accordance with the Stand-alone Method recommended by ISO s standards for testing of contact lens disinfecting solutions. Solution samples were isolated after or hours of disinfection, diluted, and plated onto agar containing clinical microbial isolates. Solution samples of () containing polyquaternium- and Aldox or () containing polyquaternium- and alexidine dihydrochloride (PQ-ALEX) were challenged with ISO panel organisms and Acanthamoeba. Both solutions exceeded the ISO specifications for the stand-alone test (Fig.). disinfection activity was greater than (p <.) against ISO strains of Serratia marcescens (log reduction of. vs..9, respectively) and Fusarium solani (log reduction of. vs..8, respectively), as shown in Figure. Figure. Efficacy of test solutions against ISO panel organisms in Stand-alone test. *, p <.. Average of log reduction h h h h h h h h h h S. aureus ATCC 8 P. aeruginosa ATCC 9 * * S. marcescens ATCC88 C. albicans ATCC F. solani ATCC disinfection activity was also superior to a against S. aureus (log reduction of. vs.., respectively) clinical isolates, as shown in Figure. Figure. Efficacy of test solutions against clinical isolates of Staphylococcus aureus in Stand-alone test. **, p <.. Average of log reduction ** ** h h h h S. aureus S. aureus activity was also superior to against clinical isolates, including Serratia marcescens (log reduction of. vs.. log, respectively as shown in figure A). Figure. (A & B) Effi cacy of test solutions against clinical isolates of Gram-negative species in Stand-alone test. *, p <.; **, p <.. Average of log reduction h h h h h h h h P. aeruginosa * * * ** ** P. aeruginosa S. marcescens S. marcescens activity was also superior to against Delftia acidovorans (log reduction of.9 vs.., respectively as shown in figure B), Stenotrophomonas maltophilia (log reduction of. vs..8, respectively as shown in figure B). Average of log reduction h h h h h h h h Acineto. sp 8 ** ** ** ** D. acidovorans P. fluorescens 9 Steno. maltophilia Candida albicans (log reduction of. vs.., respectively as shown in fi gure ) after hours of disinfection. Figure. Efficacy of contact lens care products against clinical isolates of Candida albicans and Fusarium solani in Stand-alone test. *, p <.; **, p <.. Average of log reduction ** ** ** ** h h h h h h h h C. albicans GDH C. albicans GRI 8 * * F. solani F. solani Clinical isolates are more resistant to disinfection. A solution containing polyquaternium- and alexidine dihydrochloride ( ) has demonstrated a broad and superior antimicrobial spectrum against clinical isolates, particularly for the Gram-negative bacteria Serratia marcescens, Stenotrophomonas maltophilia, and Delftia acidovorans, and for the clinical isolates of Candida albicans. Poster, British Contact Lens Association Meeting. Burmingham, UK. May,. RL-Compendium-Rebuild.indd - // :8 AM

Evaporation Effects on the Efficacy of Contact Lens Multi-Purpose Solutions Hayes Powell MS; Simon Kilvington PhD; Anthony Lam BS; Lisa Hoong BS; Santa Ana, CA, USA; James Lonnen PhD; Leicester, UK sustains antimicrobial activity even under non-compliant conditions. Other solutions like and Biotrue MPS lost their efficacy after evaporation. Background: Non-compliance is a significant factor in contact lens-related microbial keratitis. Typical non-compliance behaviors are reuse and topping off of solutions, as well as failing to recap lens cases during soaking, which results in evaporation. Objective: Evaluate the impact of partial evaporation on the antimicrobial efficacy of and other contact lens multi-purpose solutions against fungi and Acanthamoeba. Method: Each solution was evaporated under a stream of air to x and x concentrations by weight, challenged with C. albicans, F. solani or A. castellanii trophozoites and assessed for log kill (efficacy) for each organism at hrs contact time. Fungal biocidal assays were performed according to ISO 9 using automated serial dilution equipment. Acanthamoeba trophozoite viability was determined by serial dilution and most probable number calculation as described previously., ReNu MPS, AQuify MPS,, Biotrue MPS experienced no significant loss in efficacy against any organism (P<.) at x or x concentrations. % biocidal efficacy 9 8 Figure. Effect of evaporation on biocidal activity of F. solani C. albicans A. castellanii RVL RVL x RVL x concentration 8 efficacy was reduced by % 9% against C. albicans and F. solani at x or x concentration (P<. and P<.). For A. castellanii, a % loss occurred at x (P<.). % biocidal efficacy 9 8 Figure. Effect of evaporation on biocidal activity of F. solani C. albicans A. castellanii 8 OFR OFR x OFR x concentration As for Biotrue MPS, efficacy was significantly reduced by 8% (P<.) against C. albicans (data not shown). Reduction of antimicrobial efficacy on evaporation occurred with other multi-purpose solutions, but was not observed with because of the unique combination of polyquaternium- and alexidine in an optimal base formula. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. and Journal of Optometry, ():-, July. 9 9 RL-Compendium-Rebuild.indd 8-9 // :8 AM

Biocompatibility Assessment and Clinical Performance of a New Contact Lens Multi-Purpose Solution In vitro Biocompatibility Assessment of Contact Lens Multi-Purpose Solutions with Silicone Hydrogel Lenses Ling Huang OD, PhD, FAAO; Eugenia Kao, OD; Lauren Crawford; Santa Ana, CA USA is less cytotoxic than. Objective: One of the objectives is to evaluate the potential cytotoxicity of with hydrogel and silicon hydrogel lenses. Previous studies have reported that certain may lead to disruption of corneal epithelial barrier function in vitro suggesting some cytotoxic influences from these at the ocular surface. Method: The lenses were soaked in ml of the test solutions, in triplicate, for four days. The lenses were evaluated for cytotoxity in vitro using mouse fibroblasts according to USP criteria per FOA/ISO guidance (Table ). Table. USP in vitro cytoxicity direct contact test criteria Grade Reactivity Description of the Reactive Zone None No detectable zone around or under specimen Slight Some malformed or degenerated cells under specimen Mild Zone limited to area under specimen Moderate Zone extends. to. cm beyond specimen Severe Zone extends greater than. cm beyond specimen Solutions:, Lenses: Sofl ens 8 (Polymacon, Bausch & Lomb), Acuvue Advance (Galyfilcon A, Vistakon), O Optix (Lotrafilcon B, CIBA Vision), PureVision (Balafilcon A, Bausch & Lomb) and Biofinity (Comfilcon A, CooperVision) lenses. In vitro cytotoxicity showed that lenses treated with were less cytotoxic overall compared to. Table. Cell viability in the presence of -cycled lenses by direct contact assay. Overall, demonstrated higher cell cytotoxicity, with grade. -cycled CLs showed minimal cytotoxicity with grades - for most lens combinations. In vitro Cytotoxicity Scores according to USP Direct Contact Test Criteria Cytotoxicity Scores Pure- Acuvue Soflens O Vision Advance Optix 8 Biofinity Latex rubber (+ve control) Polypropylene pellets (-ve control) In vitro cytotoxicity showed that -treated lenses were less cytotoxic overall compared to. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. and Journal of Optometry, ():-, July. Ling Huang OD, PhD, FAAO; Amit Agarwal; Lauren Crawford; Santa Ana, CA, USA is less cytotoxic than (and other solutions) in vitro using human corneal epithelial cells. Background: Previous studies have reported that the use of certain MPS may lead to disruption of corneal epithelial barrier function in vitro, suggesting some cytotoxic influences from these MPS at the ocular surface. Objectives: () Evaluate potential cytotoxic effects of six MPS and () assess biocompatibility of MPS-cycled silicone hydrogel contact lenses on human corneal epithelial cells (HCEC). Solutions:, COMPLETE Easy Rub MPS,, Express, AQuify MPS, ReNu MultiPlus MPS Lenses: ACUVUE OASYS (Senofilcon A), PureVision (Balafilcon A), Air Optix (Lotrafilcon B), Biofinity (Comfilcon A) Method : Different MPS-treated contact lenses were evaluated for cytotoxity in vitro using human corneal epithelial cells according to USP criteria (Table ). Table. USP in vitro cytoxicity direct contact test criteria Grade Reactivity Description of the Reactive Zone None No detectable zone around or under specimen Slight Some malformed or degenerated cells under specimen Mild Zone limited to area under specimen Moderate Zone extends. to. cm beyond specimen Severe Zone extends greater than. cm beyond specimen Overall, and Express demonstrated the highest cell cytotoxicity with grades -. showed less cytotoxicity with grades - for all soft contact lens combinations (Figure ). Figure. Effect of MPS-cycled SiHy Contact Lenses on Cell Viability by direct contact assay Solution Lens COMPLETE Easy Rub MPS AQuify MPS ReNu MultiPlus MPS Express ACUVUE OASYS (Senofi lcon A) PureVision (Balafi lcon A) Air Optix (Lotrafi lcon B) Biofi nity (Comfi lcon A) Study continued next page RL-Compendium-Rebuild.indd - // :8 AM

In vitro Biocompatibility Assessment of Contact Lens Multi-Purpose Solutions with Silicone Hydrogel Lenses Ling Huang OD, PhD, FAAO; Amit Agarwal; Lauren Crawford; Santa Ana, CA, USA maintains better cell viability and barrier function than. Soft contact lenses, including SiHy lenses, are least compatible with. Method : Human corneal epithelial cells were treated with various MPS in vitro for a short period of time (- min) where MPS cytotoxity was assessed based on cell survival and viability (Figure ). and Express induced significant loss of cell viability at and min (Figure ). and Express are the most cytotoxic, as loss of cell viability in the presence of these was not significantly different from that of the BAC after minutes of exposure. (and COMPLETE Easy Rub MPS, AQuify MPS, ReNu MultiPlus MPS) did not induce significant loss of cell viability compared to the media and PBS controls. Statistical analysis performed with OneWay ANOVA. * = P <. ** = P <. = P <. ABS Figure. Effect of contact lens MPS on HCEC Viability examined by MTT assay..... Media PBS COMPLETE Easy Rub MPS Cell viability at mins ReNu MultiPlus MPS Express Aquify MPS BAC = P <. ABS..... Media PBS COMPLETE Easy Rub MPS Cell viability at mins Express ReNu MultiPlus MPS ** Aquify MPS BAC ** = P <. = P <. and Express exhibited the most negative affects on cell viability. Soft contact lenses, including SiHy lenses, used in this study are less compatible with and Express. Negative effects of MPS on cell survival have been reported to correlate with other changes in corneal function, including permeability suggesting that HCEC may serve as an adequate model for in vitro assays to evaluate the biocompatibility of different MPS-CLs combinations. Poster, Association for Research in Vision and Ophthalmology meeting. May -, Fort Lauderdale, FL. Cell viability at mins. ABS... *. Media PBS COMPLETE Easy Rub MPS ReNu MultiPlus MPS Express Aquify MPS BAC * = P <. ** = P <. = P <. RL-Compendium-Rebuild.indd - // :8 AM

A Clinical Safety and Acceptability Evaluation of a Novel Multi-Purpose Disinfecting Solution Nick Tarantino, OD, FAAO; Eugenia Kao, OD; Ling Huang, OD, PhD, FAAO; Santa Ana, CA, USA; Dave A. Ziegler, OD, FAAO; Milwaukee, WI, USA delivers excellent lens cleaning across all SiHy and soft contact lenses. has x fewer adverse events than OPTI- FREE. Objective: Confirm that the robust disinfection action of did not affect patient safety and acceptability compared to. Method: subjects participated in a -month, double-masked, parallel group evaluation. Five lens materials were evaluated. Subjects were randomly assigned in a : ratio to either use or lens cleanliness, adverse event and overall lens comfort were assessed. Solutions:, Lenses: ACUVUE ADVANCE (Galyfilcon A), PureVision (Balafilcon A), O Optix (Lotrafilcon B), Air Optix (Lotrafilcon B), FDA Group IV materials (e.g., Etafilcon A), Biofinity (Comfilcon A) Participants: subjects delivers excellent lens cleaning across all SiHy and soft contact lens as shown in graph. (The cleanliness of new lenses is measured at approximately reflectance units.) Graph. Lens reflectance: means with error bars Soiled Clean Reflectance Units ( - max) All Lenses Graph. Lens r ectance: means with error bars Galyfilcon A Lenses Balafilcon A Lenses Lotrafilcon B Lenses Group IV Lenses Comfilcon A Lenses New lenses Fewer subjects reported adverse events with than with during the -month follow-up (Graph ). Subjects (%) Graph. Subjects (%) reporting at least one adverse event... 8..... X FEWER adverse events.8% OcuTec p =..8% Adverse events included reports of solution hypersensitivity, conjunctivitis, and keratitis. is a highly effective disinfectant soft lens care solution, with a kill rate exceeding the standard requirements for panel organisms and clinical isolates. It is therefore remarkable that this multi-purpose disinfecting solution has also been found to be gentle to ocular tissue and acceptably comfortable for patient use on a daily basis with all lenses, including silicone hydrogel lenses. The rate of adverse events reported by subjects using was significantly lower than the rate of adverse events reported by subjects using. Poster, British Contact Lens Association Meeting. Burmingham, UK. May,. RL-Compendium-Rebuild.indd - // :8 AM

8 A Six-Month Clinical Evaluation of the Safety and Acceptability of a Novel Multi-Purpose Disinfecting Solution Nicholas Tarantino, OD, FMO; Eugenia Kao, OD; Santa Ana, CA, USA offers excellent lens wearing comfort across all types of soft contact lenses, and offers excellent lens wearing comfort over time. is gentle on ocular tissue and shows low corneal staining across all types of soft contact lenses. Objective: Objective of the study is to compare the clinical safety and acceptability of and when used with a variety of silicone and hydrogel lenses over months of daily wear. Method: -month, double-masked, parallel-group evaluation. Subjects were adapted wearers of the lens materials they wore in the study. Solution assignments were randomized according to a pre-determined schedule. For every subject using the control solution ( ) subjects used the test solution ( ). Subjects followed manufacturer-recommended label instructions. Follow-up visits were scheduled at Days,, 9, and 8 days. One set of worn lenses was collected from each subject at the end of the manufacturer s recommended replacement cycle and evaluated using laboratory-based lens cleanliness analyses. Solutions: and ACUVUE ADVANCE (Galyfilcon A), PureVision (Balafilcon A), ptix, (Lotrafilcon B) / Air Optix (Lotrafilcon B), FDA Group IV materials (e.g., Etafilcon A ), Biofinity (Comfilcon A) Participants: subjects offers excellent lens wearing comfort across all types of soft contact lenses (Figure ). Figure. Overall lens comfort: mean scores at Day 8 (across all soft contact lenses) 9 8 All lenses ACUVUE ADVANCE (Galyfilcon A) PureVision (Balafilcon A) ptix /AirOptix (Lotrafilcon B) FDA Group IV (e.g., etafilcon A) Biofinity (Comfilcon A) offers excellent lens wearing comfort among all lenses at any time point (Figure ). Figure. Lens comfort means with error bars Mean Score 9 8 Baseline Day Day Day 9 Day 8 In terms of change from baseline staining levels, no statistical significant differences were found among all lenses at Day 8 with (Figure ). Figure : Corneal staining by visit (all lenses) Percent of Subjects 9 8 Baseline Day Day Day 9 Day 8 None Trace Mild Moderate Severe is gentle to ocular tissue and acceptably comfortable for patients to use on a daily basis with all types of soft contact lenses, including silicone hydrogel lenses. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. RL-Compendium-Rebuild.indd - // :8 AM

9 Clinical Evaluation of a New Contact Lens Solution When Used in Conjunction with Two Silicone Hydrogel Lenses During Short Term Wear Daniel Tilia, MS; Percy Lazon de la Jara, PhD ; Rebecca Weng, B.Optom ; Thomas Naduvilath, PhD; Mark. D.P. Willcox, PhD; Brien A Holden, PhD produced less signs of irritation on insertion, lower levels of Solution-Induced Corneal Staining (SICS), and less ocular redness after days versus, while maintaining the same levels of comfort. Objective: Evaluate and compare short-term clinical performance of and when used in conjunction with types of silicone hydrogel contact lenses. Method: Contact lens wearers were randomized to wear a galyfilcon A lens (ACUVUE ADVANCE ) in eye and a balafilcon A lens (PureVision ) in the other. The lenses had been soaked overnight in either containing polyquaternium- and alexidine dihydrochloride or. The lenses were worn daily for days and disinfected each night in the same type of solution as the original overnight soaking. Solution use was crossed over with randomized order, and new lenses were used when solution type was changed. Subjects were clinically assessed hours after initial insertion on Day and after hours of wear on Day. Subjective ratings (8 variables, rated from to ) assessing ocular comfort and vision were collected during clinical visits and after hours of daily wear. Preference for a solution was collected at the conclusion of the study. Solutions:, Lenses: ACUVUE ADVANCE (Galyfilcon A), PureVision (Balafilcon A) Participants: Out of the contact lens wearers, 8 were included in the analysis. was associated with less SICS than (Fig. ). Figure : Difference in overall incidence of SICS between MPSs. Mean SICS Incidence by Solution Incidence (%) X LESS SICS.8 p =. 9. N = 8 patients x eyes x visits =.8% = / = eyes out of treated with OcuTec developed SICS 9.% = / = eyes out of treated with developed SICS Bulbar and limbal redness were significantly less with than after days (Fig. and ). Figure : Significant differences in bulbar redness after days of contact lens wear. More Redness Redness (-) Less Redness..8..8 Bulbar Redness: Day p =.9 p =.9 Superior Inferior Figure : Significant differences in limbal redness after days of contact lens wear. More Redness Redness (-) Less Redness..9 Limbal Redness: Day p <. p =. p =.9....8 Nasal Temporal Inferior Short-term comfort was similar for both solutions during Day (Fig. ). Figure : Comfort ratings during day. Comfort Comfort (-) Worse Comfort 8 Comfort: Day p =.8 p =.8 p =. 8. 8.8 8.8 9. Also no difference at days -.8. Insertion Hours End of Day The new solution containing alexidine dihydrochloride and polyquaternium- produced, lower levels of SICS, less ocular redness after days and was as comfortable as the commercial solution containing polyquaternium- ( ), during short term wear. Poster, British Contact Lens Association Meeting. Burmingham, UK. May,. RL-Compendium-Rebuild.indd 8-9 // :8 AM

Sponsored by Abbott Medical Optics Inc. References Willcox MDP, Carnt N, Diec J, Naduvilath T, Evans V, Stapleton F, Iskandar S, Harmis N, Lazon de la Jara P, Holden BA. Contact Lens Case Contamination During Daily Wear of Silicone Hydrogels. Peer-reviewed article from Optometry and Vision Science, Vol. 8, No., July. Kilvington S, Powell C, Lam A, Nikolic M, Brady N. Antimicrobial Properties of a New Multi-Purpose Contact Lens Disinfectant Solution. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. Zhu H, Bandara R, Masoudi S, Wu D, Willcox MDP. Evaluation of Antimicrobial Efficacy of Multipurpose Solutions against Clinical Microbial Isolate. Poster, British Contact Lens Association Meeting. Burmingham, UK. May,. Powell H, Kilvington S, Lam A, Hoong L, Lonnen J. Evaporation Effects on the Efficacy of Contact Lens Multipurpose Solutions. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. Huang L, Kao E, Crawford L. Biocompatibility Assessment and Clinical Performance of a New Contact Lens Multipurpose Solution. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. Huang L, Agarwal A, Crawford L. In vitro Biocompatibility Assessment of Contact Lens Multi-purpose Solutions with Silicone Hydrogel Lenses. Poster, Association for Research in Vision and Ophthalmology meeting. May -, Fort Lauderdale, FL. Tarantino N, Kao E, Huang L, Ziegler DA. A Clinical Safety and Acceptability Evaluation of a Novel Multi-Purpose Disinfecting Solution. Poster, British Contact Lens Association Meeting. Burmingham, UK. May,. Tarantino N, Kao E. A Six-Month Clinical Evaluation of the Safety and Acceptability of a Novel Multi-Purpose Disinfecting Solution. Poster, American Academy Optometry. Nov. -9,. San Francisco, CA. Tilia D, Lazon de la Jara P, Weng R, Naduvilath T, Willcox MDP, Holden BA. Clinical Evaluation of a New Contact Lens Solution When Used in Conjunction with Two Silicone Hydrogel Lense During Short Term Wear. Poster, British Contact Lens Association Meeting. Burmingham, UK. May,. Kilvington S, Huang L, Kao E, Powell C. Development of a new contact lens multipurpose solution: Comparative analysis of microbiological, biological and clinical performance. Journal of Optometry, Vol., No., June. Trademarks REVITALENS OCUTEC and OCUTEC are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. OPTI-FREE Express and OPTI-FREE RepleniSH are registered trademarks of Alcon Laboratories. ReNu and PureVision are registered trademarks of Bausch & Lomb. NIGHT & DAY, O OPTIX and Clear Care are registered trademarks of CIBA Vision. Acuvue and Acuvue Oasys are registered trademarks of Johnson & Johnson Vision Care Inc. Proclear is a registered trademark of Cooper Vision. Abbott Medical Optics Inc., Santa Ana, CA 9 www.abbottmedicaloptics.com..-cn RL-Compendium-Rebuild.indd // :8 AM