Safety Evaluation of Systane Ultra® in Contact Lens Wearers
1
Conclusion: Current surgical treatments, which include lam- ellar keratoplasty and combined superficial keratectomy with conjunctival autograft, may lead to complications such as cor- neal perforation or recurrence of marginal keratitis in the graft. The use of rigid gas-permeable contact lenses is a viable option to improve vision and prolong the necessity of surgical inter- vention in Fuchs’ superficial marginal keratitis. Poster 5 Safety Evaluation of Systane UltraÒ in Contact Lens Wearers David Kading, O.D., Specialty Eyecare Group, 11830 NE 128 th Street, Kirkland, Washington 98034 Objective: The aim of this study was to evaluate the safety of Systane UltraÒ containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Solution) in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop was included as a control. Participants: This was an investigator- and patient- masked, single-site, randomized, prospective study of 2 weeks duration involving 47 successful contact lens wearers with good ocular and general health. Methods: At the screening visit, eligible subjects’ baseline visual acuities and biomicroscopy findings were recorded. Subjects were randomly assigned to receive either the test solution or the control with masked labeling in prenum- bered kits. Subjects were instructed to instill their assigned test article in both eyes 15 minutes before lens insertion, at least one drop during lens wear and another drop immedi- ately after lens removal. After 14 days, biomicroscopy, in- cluding sum corneal staining and visual acuity results, were recorded. Results: There were no adverse events documented for ei- ther the test or control solution. Biomicroscopic evaluations were within normal limits for both test and control solu- tions and visual acuity was not affected by treatment. Conclusions: These results indicate that Systane Ultra is compatible for use with contact lenses. (Investigators received grant support funded by Alcon Laboratories.) Poster 6 Fungicidal Activity of Contact Lens Care Solutions Challenged With Clinical and Environmental Isolates of Fusarium Cindy L. McAnally, B.S., and Roya N Borazjani, Ph.D., Alcon Laboratories, 6201 South Freeway, Fort Worth, Texas 76134 Background: Because of recent outbreaks of Fusarium ker- atitis associated with a multipurpose contact lens care solu- tion, the fungicidal efficacy of 4 multipurpose solutions and 2 hydrogen peroxide systems was evaluated against clinical and environmental isolates of Fusarium based on the Inter- national Organization for Standardization (ISO) and the U.S. Food and Drug Administration (FDA) Stand-Alone Procedure for disinfecting products. Method: Marketed solutions were challenged with clinical and environmental strains of Fusarium based on the ISO and FDA Stand-Alone Procedure for disinfecting products. Solutions were sampled for surviving microorganisms at the recommended disinfection time, 24 hours and 7 and 14 days. Serial dilutions and pour plates were prepared us- ing validated recovery media. Appropriate incubation times and temperatures were observed. The numbers of viable microorganisms were enumerated and log reductions calcu- lated. The following antimicrobial systems were evaluated: 1) PolyquadÒ (polyquaternium-1)/AldoxÒ (myristamido- propyl dimethylamine), 2) PHMB (polyhexamethylene biguanide), and 3) hydrogen peroxide (3% hydrogen peroxide w/neutralizing system). Results: Solutions containing Polyquad/Aldox and 3% hy- drogen peroxide showed similar log reduction activity at the disinfection time (2.0 logs or greater). Solutions con- taining PHMB showed lower log reduction activity than Polyquad/Aldox and hydrogen peroxide systems at the dis- infection time (1.0 log or less). At extended storage times of 7 and 14 days, the Polyquad/Aldox and PHMB systems were effective against regrowth for all microorganisms. Only solutions containing 3% hydrogen peroxide showed regrowth of one or more microorganisms when stored for extended periods. Conclusion: Contact lens care solutions containing the dual antimicrobial system Polyquad/Aldox were effective against clinical and environmental isolates of Fusarium at the disin- fection time as well as extended storage times of 7 and 14 days. Hydrogen peroxide systems were effective at the disin- fection time, but because of neutralization (at disinfection time) allowed regrowth of one or more microorganisms at 7 and/or 14 days extended storage. Both PHMB and Polyquad/Aldox solutions were effective at extended storage times and showed no regrowth of microorganisms. The results of this study indicate the importance of choosing a solution with a robust antimicrobial system that kills at the disinfection time as well as inhibits regrowth of clinical and environmental isolates of Fusarium. (Investigators are employees of Alcon Laboratories.) Poster 7 Fluorescence Measurements in Contact Lenses With a Novel Confocal Microscope Ryan Gustus, Matthew S. Muller, M.S., Dean A. VanNasdale, O.D., and Anne Elsner, Ph.D., Indiana University School of Optometry, 800 E. Atwater St., Bloomington, Indiana 47405 Background: We measured the retention of sodium fluores- cein in contact lenses, because topical fluorescein is 288 Optometry, Vol 80, No 6, June 2009
-
Upload
david-kading -
Category
Documents
-
view
213 -
download
1
Transcript of Safety Evaluation of Systane Ultra® in Contact Lens Wearers
288 Optometry, Vol 80, No 6, June 2009
Conclusion: Current surgical treatments, which include lam-ellar keratoplasty and combined superficial keratectomy withconjunctival autograft, may lead to complications such as cor-neal perforation or recurrence of marginal keratitis in the graft.The use of rigid gas-permeable contact lenses is a viable optionto improve vision and prolong the necessity of surgical inter-vention in Fuchs’ superficial marginal keratitis.
Poster 5
Safety Evaluation of Systane Ultra� in Contact LensWearers
David Kading, O.D., Specialty Eyecare Group, 11830 NE128th Street, Kirkland, Washington 98034
Objective: The aim of this study was to evaluate the safetyof Systane Ultra� containing polyethylene glycol 400 andpropylene glycol demulcents with hydroxypropyl-guar as agelling agent (Test Solution) in contact lens wearers. Acomparison to a currently marketed contact lens rewettingdrop was included as a control.Participants: This was an investigator- and patient-masked, single-site, randomized, prospective study of 2weeks duration involving 47 successful contact lenswearers with good ocular and general health.Methods: At the screening visit, eligible subjects’ baselinevisual acuities and biomicroscopy findings were recorded.Subjects were randomly assigned to receive either the testsolution or the control with masked labeling in prenum-bered kits. Subjects were instructed to instill their assignedtest article in both eyes 15 minutes before lens insertion, atleast one drop during lens wear and another drop immedi-ately after lens removal. After 14 days, biomicroscopy, in-cluding sum corneal staining and visual acuity results, wererecorded.Results: There were no adverse events documented for ei-ther the test or control solution. Biomicroscopic evaluationswere within normal limits for both test and control solu-tions and visual acuity was not affected by treatment.Conclusions: These results indicate that Systane Ultra iscompatible for use with contact lenses.
(Investigators received grant support funded by AlconLaboratories.)
Poster 6
Fungicidal Activity of Contact Lens Care SolutionsChallenged With Clinical and Environmental Isolates ofFusarium
Cindy L. McAnally, B.S., and Roya N Borazjani, Ph.D.,Alcon Laboratories, 6201 South Freeway, Fort Worth,Texas 76134
Background: Because of recent outbreaks of Fusarium ker-atitis associated with a multipurpose contact lens care solu-tion, the fungicidal efficacy of 4 multipurpose solutions and2 hydrogen peroxide systems was evaluated against clinical
and environmental isolates of Fusarium based on the Inter-national Organization for Standardization (ISO) and theU.S. Food and Drug Administration (FDA) Stand-AloneProcedure for disinfecting products.Method: Marketed solutions were challenged with clinicaland environmental strains of Fusarium based on the ISOand FDA Stand-Alone Procedure for disinfecting products.Solutions were sampled for surviving microorganisms atthe recommended disinfection time, 24 hours and 7 and14 days. Serial dilutions and pour plates were prepared us-ing validated recovery media. Appropriate incubation timesand temperatures were observed. The numbers of viablemicroorganisms were enumerated and log reductions calcu-lated. The following antimicrobial systems were evaluated:1) Polyquad� (polyquaternium-1)/Aldox� (myristamido-propyl dimethylamine), 2) PHMB (polyhexamethylenebiguanide), and 3) hydrogen peroxide (3% hydrogenperoxide w/neutralizing system).Results: Solutions containing Polyquad/Aldox and 3% hy-drogen peroxide showed similar log reduction activity atthe disinfection time (2.0 logs or greater). Solutions con-taining PHMB showed lower log reduction activity thanPolyquad/Aldox and hydrogen peroxide systems at the dis-infection time (1.0 log or less). At extended storage timesof 7 and 14 days, the Polyquad/Aldox and PHMB systemswere effective against regrowth for all microorganisms.Only solutions containing 3% hydrogen peroxide showedregrowth of one or more microorganisms when stored forextended periods.Conclusion: Contact lens care solutions containing the dualantimicrobial system Polyquad/Aldox were effective againstclinical and environmental isolates of Fusarium at the disin-fection time as well as extended storage times of 7 and 14days. Hydrogen peroxide systems were effective at the disin-fection time, but because of neutralization (at disinfectiontime) allowed regrowth of one or more microorganismsat 7 and/or 14 days extended storage. Both PHMB andPolyquad/Aldox solutions were effective at extended storagetimes and showed no regrowth of microorganisms. Theresults of this study indicate the importance of choosing asolution with a robust antimicrobial system that kills at thedisinfection time as well as inhibits regrowth of clinicaland environmental isolates of Fusarium.
(Investigators are employees of Alcon Laboratories.)
Poster 7
Fluorescence Measurements in Contact Lenses With aNovel Confocal Microscope
Ryan Gustus, Matthew S. Muller, M.S., DeanA. VanNasdale, O.D., and Anne Elsner, Ph.D., IndianaUniversity School of Optometry, 800 E. Atwater St.,Bloomington, Indiana 47405
Background: We measured the retention of sodium fluores-cein in contact lenses, because topical fluorescein is
