ORLANDO, FL (May 5, 2014) – In a year-long study designed to observe ‘real-life’ contact lens fitting and wearing behaviors, registered patients who were prescribed 1-DAY ACUVUE® MOIST® Brand Contact Lenses (etafilcon A) reported a low incidence of ocular adverse events (AEs), with only three non-serious contact lens related AEs that resulted in a doctor’s office visit in 471 years of patient wear (0.6%/year including no reported symptomatic corneal infiltrative events [CIEs]). Findings were presented at the 2014 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
The data was part of a larger observational study designed to evaluate the safety performance of 1-DAY ACUVUE® MOIST® and 1-DAY ACUVUE® TruEye® Brand Contact Lenses (Johnson & Johnson Vision Care, Inc.) as prescribed by doctors following their normal prescribing procedures, and as used by patients following normal wearing behaviors. For wearers of 1-DAY ACUVUE® TruEye® Brand (narafilcon B), the rate of adverse events that resulted in an office visit was 1.6 percent per year of which 0.4 percent per year were symptomatic CIEs.
“The rate of adverse events observed in this study is between 4 and 10 times lower than that reported in any other studies that evaluated reusable lenses published to date1-4.,” according to lead author Robin L Chalmers, OD, FAAO, FBCLA, Clinical Trial Consultant. “Of 1,171 wearers of these two daily disposable contact lens brands, only 11, or approximately one-percent, had contact lens-related complications that prompted a visit to the eye care practitioner, and only two events were symptomatic CIEs.”
“1-DAY ACUVUE® MOIST® and 1-DAY ACUVUE® TruEye® delivered positive health outcomes among patients broadly representative of the general contact lens wearing population, who wore their lenses in ‘real world’ conditions,” adds co-author, Sheila Hickson-Curran, BSc(Hons), MCOptom, FAAO, DipCCLRT, Director, Global Strategic Medical Affairs, Johnson & Johnson Vision Care, Inc. “Because this research was specifically designed to study the safety outcomes with these daily disposable brands, the non-interventional study methodology did not limit how lenses were prescribed, how patients were instructed on wear and care, recorded patient behaviors that occur in real-life, and the results are more reflective of actual wear conditions than in controlled studies where safety is reported as an outcome.”
About the Study
The 1-DAY ACUVUE® TruEye® or 1-DAY ACUVUE® MOIST® Brands Performance Overview (TEMPO) Registry enrolled a total of 1,171 subjects, ages 8-76 years old, 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.
After consenting/assenting to the registry, patients who were at least 8 years of age were asked to complete self-administered online questionnaires at registration, after two weeks, four months and 12 months. Adverse events were reported by subjects if they responded “yes” to the following question: “Since we last contacted you, have you experienced a red or painful eye while wearing your contact lenses that required a visit to an eye doctor or emergency room?” All “yes” responses were investigated and clinical charts were reviewed independently by three masked clinical researchers who are known world experts in cornea and contact lenses.
The TEMPO Registry observed 960 years of wear: 471 years of hydrogel daily disposable wear (1-DAY ACUVUE® MOIST®) and 489 years of silicone hydrogel daily disposable wear (1-DAY ACUVUE® TruEye®). Years of wear were calculated by lens brand from the date of the registration visit to the date of the last survey completed by each subject, and prevalence of risk factors was the percentage of subjects reporting the factor at any survey during the observation period. -continued-
Wearers of 1-DAY® ACUVUE® MOIST-Study/2
In that period, wearers of 1-DAY ACUVUE® MOIST® reported 3 non-serious contact lens-related adverse events that resulted in office visits (0.6 percent x / year with no symptomatic CIEs), 5 reports without office visits (1.1 percent/year), and 1 adverse event that was not soft contact lens related (0.2 percent/year).
Wearers of 1-DAY ACUVUE® TruEye® reported 8 adverse events that resulted in office visits (1.6 percent/year with 2 symptomatic CIEs (0.4 percent/year)), 8 reports without office visits (1.6 percent/year), and 4 with events that were not soft contact lens related (0.8 percent/year).
This observational/surveillance registry relied on patient reports of symptomatic adverse events that led them to seek clinical care using methodology similar to that used in FDA mandated post-market surveillance of contact lenses. These results should be considered in conjunction with other clinical results on the safety and efficacy of daily disposable etafilcon and narafilcon contact lenses, which also generally show low rates of such events. Although no symptomatic infiltrative events were reported in this study with etafilcon contact lenses, such events can occur with daily disposable lenses, including 1-DAY ACUVUE® MOIST® and 1-DAY ACUVUE® TruEye®, as noted in the product labeling.
The study was supported by funding from Johnson & Johnson Vision Care, Inc. Dr. Robin Chalmers is a paid consultant for Johnson & Johnson Vision Care, Inc.
Source: Chalmers, RL, Hickson-Curran, S, Keay, L, Gleason, B, “Safety of Hydrogel and Silicone Hydrogel Daily Disposables in a Large Post-Market Surveillance Registry – The TEMPO Registry.” ARVO 2014 e-abstract # 1914962.
ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON® Division of Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting www.ACUVUEProfessional.com.
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 additional information, visit www.jnjvc.com.
1-DAY ACUVUE® MOIST® and 1-DAY ACUVUE® TruEye® are trademarks of Johnson & Johnson Vision Care, Inc.
Note: The narafilcon B version of 1-DAY ACUVUE® TruEye®, which is no longer marketed, was used in this study as it was the product available in the United States at the time of the registry. This product differs slightly from 1-DAY ACUVUE® TruEye® (narafilcon A), which is currently available worldwide. Both are daily disposable silicone hydrogel lenses and are from the same material family.
References:
- Chalmers RL, Keay L, McNally J, Kern J. Multi-center case control study of the role of lens materials and care products on the development of corneal infiltrates. Optom Vis Sci. 2012; 89(3):316-25.
- Szczotka-Flynn L, Jiang Y, Raghupathy S et al. Corneal inflammatory events with daily silicone hydrogel lens wear. Optom Vis Sci 2014;91: 3-12.
- Chalmers RL, Keay L, Long B, Bergenske P, Giles T, Bullimore M. Risk factors for contact lens complications in US clinical practices. Optom Vis Sci 2010 87(10)725-735.
- Chalmers RL, Wagner H, Mitchell GL, Lam DY, Kinoshita BT, Jansen ME, Richdale KL, Sorbara L, McMahon TT. Age and other risk factors for corneal infiltrative and inflammatory events in young soft contact lens wearers from the contact lens assessment in youth (CLAY) study. IOVS, 2011 52(9)6690-6696.