EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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EW NEWS & OPINION November 2015 27 91166 EYEWORLD 11115 Sustained 30 % IOP lowering at 12, 14, and 20 hours post-dose in a 3-month study 1,2 * CHOOSE TRAVATAN Z ® Solution: A POWERFUL START INDICATIONS AND USAGE TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Dosage and Administration The recommended dosage is 1 drop in the affected eye(s) once daily in the evening. TRAVATAN Z ® Solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP-lowering effect. TRAVATAN Z ® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. IMPORTANT SAFETY INFORMATION Warnings and Precautions Pigmentation—Travoprost ophthalmic solution has been reported to increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. The long-term effects of increased pigmentation are not known. While treatment with TRAVATAN Z ® Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes—TRAVATAN Z ® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. Use With Contact Lenses—Contact lenses should be removed prior to instillation of TRAVATAN Z ® Solution and may be reinserted 15 minutes following its administration. Adverse Reactions The most common adverse reaction observed in controlled clinical studies with TRAVATAN Z ® Solution was ocular hyperemia, which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. Use in Specifi c Populations Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. For additional information about TRAVATAN Z ® Solution, please see the brief summary of Prescribing Information on the adjacent page. Help patients start strong and stay on track with the TRAVATAN Z® Solution has no FDA-approved generic therapeutic equivalent 3 * Study Design: Double-masked, randomized, parallel-group, multicenter non-inferiority comparison of the effi cacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) to TRAVATAN Z ® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. Baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322), and 24.8 mm Hg (n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z ® Solution. At the end of Month 3, the TRAVATAN Z ® Solution group had mean IOPs (95% CI) of 18.7 mm Hg (-0.4, 0.5), 17.7 mm Hg (-0.4, 0.6), and 17.4 mm Hg (-0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistical equivalent reductions in IOP (95% confi dence interval about the treatment differences were entirely within ±1.5 mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment. References: 1. Data on fi le, 2013. 2. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and effi cacy. J Glaucoma. 2007;16(1): 98-103. 3. Drugs@FDA. FDA Approved Drug Products: TRAVATAN Z page. US Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed March 31, 2015. © 2015 Novartis 4/15 TRV15086JAD Not actual patient 91166 EYEWORLD 11115 problems, cognitive issues, and others after TBI. Speaking from clinical experience Athletes and combat veterans can "absolutely" experience the same traumatic brain injury leading to vision issues, according to John D. Sheppard, MD, professor of oph- thalmology, microbiology and mo- lecular biology, and clinical director, Thomas R. Lee Center for Ocular Pharmacology, Eastern Virginia Med- ical School, Norfolk, Va. "In terms of traumatic brain injury, occipital cortex trauma and trauma to the optic nerve itself are very possible in both veterans and athletes." The whole spectrum of pathol- ogy in brain injury, according to Dr. Sheppard, is shared among them. He noted sharing of other conditions as well between these two populations, including psychosocial, motor prob- lems, and perceptual issues. Experienced in taking care of patients who have been in car accidents, patients with post-trau- matic stress disorder, and others, Dr. Sheppard noted that the astute ophthalmologist can detect prob- lems outside of ophthalmology, including sensorimotor deficits or PTSD, by taking a thorough history and appropriately directing referrals to neurology, psychology, or rehabil- itation medicine. EW Reference Dutca LM, et al. Early detection of subclini- cal visual damage after blast-mediated TBI enables prevention of chronic visual deficit by treatment with P7C3-S243. Invest Ophthalmol Vis Sci 2014;55:8330–8341. Editors' note: The physicians have no financial interests related to this article. Contact information McKee: amckee@bu.edu Sheppard: jsheppard@vec2020.com " Experts are working on neuroimaging tools, cerebrospinal fluid and blood biomarkers that would, in the future, help detect TBI and accompanying visual problems early on. The retina is often an area of focus. "