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Johnson & Johnson Vision Care, Inc. (JNJ) Release: Soft Contact Lenses Do Not Lead to 'Myopic Creep' in Children, Study Shows Largest Randomized Trial of its Kind Shows No Clinically Meaningful Difference Between Contacts and Glasses for Progression of Nearsightedness



11/12/2008 9:48:13 AM

JACKSONVILLE, Fla., Nov. 12 /PRNewswire/ -- Soft contact lens wear does not result in clinically significant acceleration in the development of nearsightedness in children and does not cause relevant increases in axial length or corneal curvature, a new study shows. Findings from the three-year study, the largest randomized trial of its kind, appear in the November issue of Investigative Ophthalmology & Visual Science, the official journal of The Association for Research in Vision and Ophthalmology.

According to the multi-site wearing trial study, which tracked the myopic progression of 484 children ages 8-11 randomly assigned to wear glasses or contact lenses, there is no clinically meaningful difference between the two forms of vision correction for the treatment of nearsightedness, a vision problem experienced by approximately one-third of the population.

The new research further dispels a long held myth that soft contact lenses increase myopia progression (a/k/a "Myopic Creep") in children more than other vision correction options.

"Children as young as eight years old who require vision correction are capable of contact lens wear and this study confirms that they can safely be fit in soft contact lenses to correct their myopia," says Jeffrey J. Walline, O.D., Ph.D., Ohio State University College of Optometry and leader of the Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study, of which this research was a part.

"Recent clinical studies have demonstrated that contact lenses provide a number of quality of life benefits to children beyond simply correcting their myopia," he adds. "The combined body of research should give both doctors and parents greater confidence in presenting children with the option of contact lens wear when vision correction is required."

Myopia affects approximately 15 percent of children in the United States, but is much higher in some other countries such as Singapore and China. It typically develops around 8 years of age and worsens until age 15 or 16. A nearsighted child has difficulty seeing objects clearly at a distance, like a blackboard, but can see clearly up-close, such as when reading a book. Myopia can be corrected with glasses, contact lenses and refractive eye surgery.

Doctors will typically evaluate a child's maturity and level of parental support in deciding whether the child is ready for contact lenses.

About the Study

The purpose of this part of the ACHIEVE study was to measure the refractive error, corneal curvature, and axial length of eight to 11 year old children randomly assigned to wear single vision glasses or soft contact lenses (1-DAY ACUVUE(R) Brand Contact Lenses or ACUVUE(R) 2 Brand Contact Lenses, VISTAKON(R), Division of Johnson & Johnson Vision Care, Inc.) for three years to compare the rate of myopic progression with each mode of correction over three years.

A total of 484 eight- to 11-year old myopic children participated in the randomized, single-masked, trial conducted from September 2003 to October 2007 at five clinical centers in the United States. Children were randomly assigned to wear spectacles (n = 237) or contact lenses (n = 247) for three years.

Among those who were assigned to wear contact lenses, 93.3 percent elected to wear 1-DAY ACUVUE(R) Brand Contact Lenses, a single use lens, rather than the other two-week modality. At the conclusion of the study, nine in ten children (90.7 percent) originally assigned to wear contact lenses at the first visit were still wearing contact lenses.

Measurements were conducted prior to randomization and annually. Nearly all (467 - 96.5%) of the subjects were examined at the final visit. The spectacle wearers progressed -1.08 +/- 0.71 D, and the contact lens wearers progressed -1.27 +/- 0.72 D (analysis of covariance, p = 0.005); although this difference is statistically significant, the difference is less than can be clinically measured. The axial growth of the spectacle wearers was 0.59 +/- 0.37 mm and 0.63 +/- 0.34 mm for the contact lens wearers (analysis of covariance, p = 0.27). The change in the steep corneal meridian was 0.05 +/- 0.69 D for the spectacle wearers and 0.10 +/- 0.70 D for the contact lens wearers (analysis of covariance, p = 0.43). These differences were not statistically significant.

The study was supported by funding from VISTAKON(R), Division of Johnson & Johnson Vision Care, Inc.

ACUVUE(R), Brand Contact Lenses are indicated for vision correction. As with any contact lenses, 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 discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON(R), Division of Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting www.jnjvisioncare.com (for eye care professionals) or www.acuvue.com (for consumers).

ACUVUE(R), ACUVUE(R) 2, 1-DAY ACUVUE(R) and VISTAKON(R) are trademarks of Johnson & Johnson Vision Care, Inc.

CONTACT: Gary Esterow of Vistakon, +1-908-216-5200, Gester1@visus.jnj.com;
or Melissa Barredo of Rpr Marketing Communications, +1-212-317-1462,
melissa.barredo@rprny.com, for Vistakon

Web site: http://www.acuvue.com/
http://www.jnjvisioncare.com/


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