Robin L Chalmers1, Sheila B Hickson-Curran2, Lisa Keay3, William J Gleason4, Roger Albright4. 1. Clinical Trial Consultant, Atlanta, Georgia, United States. 2. Director, Medical Affairs, Johnson & Johnson Vision Care, Inc., Jacksonville, Florida, United States. 3. The George Institute for Global Health, University of Sydney, Sydney, Australia. 4. Foresight Regulatory Strategies, Inc., Wilmington, Massachusetts, United States.
Abstract
PURPOSE: To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs. RESULTS: The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs. CONCLUSIONS: The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
PURPOSE: To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs. RESULTS: The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs. CONCLUSIONS: The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.
Authors: Loretta B Szczotka-Flynn; Joseph P Shovlin; Cristina M Schnider; Barbara E Caffery; Eduardo C Alfonso; Nicole A Carnt; Robin L Chalmers; Sarah Collier; Deborah S Jacobs; Charlotte E Joslin; Abby R Kroken; Carol Lakkis; Eric Pearlman; Oliver D Schein; Fiona Stapleton; Elmer Tu; Mark D P Willcox Journal: Optom Vis Sci Date: 2021-03-01 Impact factor: 2.106
Authors: Amir M Moezzi; Jalaiah Varikooty; Marc Schulze; William Ngo; Kathrine Osborn Lorenz; Danielle Boree; Lyndon W Jones Journal: Optom Vis Sci Date: 2016-06 Impact factor: 1.973