Newsroom
Preliminary Results Show Lotemax® with Topical Cyclosporine to be Effective for Relief of Dry Eye Signs and Symptoms
FOR RELEASE WEDNESDAY, DECEMBER 5, 2007
ROCHESTER, N.Y. — At the annual meeting of the American Academy of Ophthalmology, Eric D. Donnenfeld, M.D. and John D. Sheppard, M.D. presented the preliminary results of a prospective, multi-center, randomized controlled study of the effect of Bausch & Lomb’s Lotemax® (loteprednol etabonate ophthalmic suspension 0.5%) on initiation of therapy with cyclosporine.
Dr. Donnenfeld reported that use of loteprednol etabonate (Lotemax) with topical cyclosporine ophthalmic emulsion 0.05% (Restasis) provided more rapid relief of dry eye signs and symptoms with greater efficacy than the combination of topical cyclosporine and artificial tears. Long term treatment (60 days) with loteprednol etabonate did not affect IOP (p=0.22).
“The preliminary results of this clinical trial will help physicians to better manage their dry eye patients,” said Dr. Donnenfeld.
Lotemax is indicated for the treatment of steroid responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
In this analysis, 118 patients with clinically diagnosed dry eye disease were randomized to receive either loteprednol etabonate ophthalmic suspension 0.5% (test) or an artificial tear (control) in masked bottles QID for 2 weeks and then received the masked test or control drop BID plus cyclosporine BID from Day 15 to Day 60. Additional use of artificial tears was allowed as needed.
Improvement in Corneal and Conjunctival Staining
Dr. Donnenfeld reported that at day 60, there was significant improvement in corneal (p<0.005) and conjunctival staining (p<0.05) in patients randomized to the loteprednol etabonate group. Although both treatments reduced corneal staining and lissamine green staining, Lotemax with cyclosporine was more effective in all cases.
Improvement in Schirmer Test and Frequency of Adjunctive Artificial Tear Use
When normalized to baseline, Lotemax with cyclosporine significantly increased tear production by 27%, compared to 17% with artificial tears and cyclosporine over a 60-day period (p<0.005).
Reduction in Ocular Surface Disease Index (OSDI) scores
Both treatments reduced OSDI scores over a period of 60 days (p<0.05). Lotemax with cyclosporine reduced OSDI scores significantly more than artificial tears and cyclosporine (p<0.001).
Safety Outcomes
Dr. Donnenfeld reported that with long term treatment (60 days), loteprednol etabonate did not affect IOP (p=0.22).
As with other ophthalmic corticosteroids, Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva, and in mycobacterial and fungal diseases of the eye. Prolonged use may result in secondary glaucoma, cataract formation, and secondary ocular infections following suppression of the host response and/or perforation of the globe. The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. The most common adverse events in patients treated with Lotemax were abnormal vision/blurring, burning, chemosis, discharge, and dry eyes. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
# # #
About Bausch & Lomb
Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York. Bausch & Lomb’s 2006 revenues were more than $2.2 billion; it employs more than 13,000 people worldwide and its products are available in more than 100 countries. More information can be found at www.bausch.com.
Lotemax is a registered trademark of Bausch & Lomb Incorporated.
