NEW DATA SHOWS HIGH RETENTION RATES AND VERY LOW ADVERSE EVENTS IN MINORS WITH TWO ACUVUE® BRAND DAILY DISPOSABLE CONTACT LENSES
Jacksonville, FL – April 11, 2016 –Johnson & Johnson Vision Care, Inc. presented new data at a scientific research symposium of the British Contact Lens Association (BCLA) held during the Netherlands Contact Lens Conference (NCC) that showed high retention rates in children and teens wearing daily disposable ACUVUE® Brand Contact Lenses, with no corneal infiltrative events (CIEs) and very low rates of other adverse events (AEs) in this study sub-population over a one-year period.*
“This sub-analysis of children and teens from The TEMPO Registry Study showed that prescribing daily disposable contact lenses (DDCLs), whether silicone hydrogel or hydrogel, is an important step in helping to keep the rate of adverse events low with contact lens wear. This benefit is in addition to the convenience and compliance benefits of a daily disposable modality,” said Dr Robin Chalmers, OD, FAAO, a clinical trial consultant from Atlanta, Georgia, U.S. during her presentation.
The purpose of the registry was to measure the annual rate of CIEs and other AEs; the sub-analysis looked at this with a cohort of children and teens and also determined factors that affected their retention in lens wear. The subjects were followed after fitting with either 1-DAY ACUVUE® MOIST Brand Contact Lenses (etafilcon A) or 1-DAY ACUVUE® TruEye® Contact Lenses (narafilcon B). It included 202 children and teens aged 8-17 years old, with 52% who were new wearers and 48% who were experienced contact lens wearers.
There were no CIEs reported in this study and the rate of any AE was minimal at 1.1% per year for etafilcon A and 1.3% per year for narafilcon B with a combined rate of 1.2%.* Retention over one year was high at 82% for new wearers and 87% for experienced wearers after one year of observation. Drop-outs among new wearers tended to occur earlier, more in the first two weeks than with experienced wearers (41% versus 21% of all dropouts in either group), indicating the need for early follow-up visits with these younger wearers who are new to contact lens wear.
Results also showed that experienced wearers’ comfortable wearing time increased significantly with DDCLs (p=0.027), although average total wearing time did not (p=0.91). Experienced wearers’ overall opinion of contact lenses improved significantly from 45% with habitual CLs to 84% with DDCLs (p=0.0003). Subjects were asked the questions “What is your overall opinion of the performance of your contact lenses?”
“The data reinforce the benefits of DDCLs for active children and teens and that obstacles to successfully wearing contact lenses can be significantly reduced with these products,” said Anna Sulley, BSc MCOptom FBCLA FAA, Associate Director, Global Strategic Medical Affairs for EMA, Johnson & Johnson Vision Care Companies, Inc. “1-DAY ACUVUE® MOIST is an excellent option for this group of contact lenswearers.”
About The Study
The 1-DAY ACUVUE® TruEye® and 1-DAY ACUVUE® MOIST Performance Overview (TEMPO) Registry was a larger observational study designed to evaluate the safety performance as prescribed by eye care professionals following their normal prescribing procedures, and as used by patients following normal wearing behaviors. A total of 1,171 subjects, ages 8-76 years old were enrolled in 37 clinical sites across the United States, including private optometry practices, optometrists in retail/chain settings, as well as optometry colleges and teaching universities.
*This observational/surveillance registry relied on patient reports of symptomatic adverse events that led them to seek clinical care. These results should be considered in conjunction with other clinical results on the safety and efficacy of daily disposable etafilcon A contact lenses, which also generally show low rates of such events. Although no symptomatic infiltrative events were reported in this study, such events can occur with daily disposable lenses, including 1-DAY ACUVUE® MOIST, as noted in the product labelling.
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc. is committed to creating life-long solutions to vision care needs. Since the ACUVUE® Brand made its debut in 1987 as the world’s first disposable soft contact lens, the company has repeatedly brought innovative, quality, and scientific advancements to the industry. Headquartered in Jacksonville, Florida, the company has some 3,000 employees worldwide. For more information, visit www.AcuvueProfessional.com.