VISTAKON® Division of Johnson & Johnson Vision Care, Inc.
JACKSONVILLE, Fla. (April 25, 2013) – 1-DAY ACUVUE® TruEye® Brand Contact Lenses (narafilcon A) were found to have no clinically significant effect on the ocular surface of the eye as compared to non-contact lens wearers across five of six contact lens related measures associated with eye health, research shows. In addition, 1-DAY ACUVUE® TruEye® Brand (narafilcon A) was also shown to provide high levels of comfort from morning to night, comparable to wearing no lenses at all. These findings were published recently in Contact Lens & Anterior Eye, a research-based journal covering all aspects of contact lens theory and practice.
About the Study
The 74-subject, randomized, investigator-masked, parallel group study compared neophyte patients (those new to contact lenses) wearing 1-DAY ACUVUE® TruEye® Brand (narafilcon A) with patients who had not previously worn contact lenses and remained wearing their own spectacles for 12 months. Subjects between the ages of 19 and 51 who were low to moderate myopes were enrolled. Subjective comfort data, biomicroscopy, and visual acuity were recorded at an initial visit, two weeks and at one, three, six, nine and 12 months. Comfort data (1 to 5 Likert scale, where 1 is very poor and 5 is excellent) also were collected at weeks one and five by text messaging every three hours from 9:00 AM to 9:00 PM, for five days and averaging the scores for each subject. Replies received within 30 minutes of the target time were included for analysis. Slit lamp signs were graded 0 to 4 (absent, trace, mild, moderate, severe) in 0.1 increments using the Efron grading scale, and visual acuity (high and low contrast) was measured using the logMAR scale.
Comfort scores assessed at the six study visits were equivalent for contact lens wearers and spectacle wearers. Subjects wearing 1-DAY ACUVUE® TruEye® reported comfort equivalent to subjects not wearing contact lenses measured by SMS text messaging at the one month visit. Comfort remained equivalent at time-points throughout the day, with average ratings of 4.37 and 4.22 units for lens wearers and non-lens wearers, respectively.
After a full year of wear, there were no clinically significant differences between contact lens wearers and spectacle wearers for five out of six key ocular health measures: bulbar conjunctival hyperemia, limbal hyperemia, corneal staining, neovascularization, and papillary conjunctivitis. There was more conjunctival staining for contact lens wearers than spectacle wearers, although grades were low averaging only “trace” levels throughout the study.
COMFORT AND OCULAR HEALTH OF NARAFILCON A/2
Subjective scores for vision were similar for the two groups. Measured visual acuity was approximately half a line better for spectacle wearers as these subjects were provided with their full sphero-cylindrical over-refraction, compared to contact lens wearers in the best spherical corrected contact lenses.
“The novel nature of this clinical study represented a significant challenge for the contact lens under test,” says study co-author Philip B. Morgan, PhD, BSc, Director, Eurolens Research, The University of Manchester, United Kingdom. “It’s pleasing that not only can modern contact lens materials and designs now be tested against people not using contact lenses, they are able to offer comparable performance for comfort and certain key indicators of eye health.”
The study was sponsored by VISTAKON® Division of Johnson & Johnson Vision Care, Inc.
Source: Morgan PB, et al. Ocular physiology and comfort in neophyte subjects fitted with daily disposable silicone hydrogel contact lenses. Contact Lens & Anterior Eye (2012), http://dx.doi.org/10.1016/j.clae.2012.12.001
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.
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