Increasing Tear Production
A Difference Proven in Clinical Studies
In a pivotal trial, Dry Eye patients treated with RESTASIS® Ophthalmic Emulsion showed significant improvement in key signs. RESTASIS® is the first and only Rx to increase tear production and demonstrate
- Schirmer Scores1
- Patients using RESTASIS® Ophthalmic Emulsion had 3 times mean improvement at 3 months and 4 times mean improvement at 6 months vs patients using vehicle.
- Goblet Cell Density2
- Patients treated with RESTASIS® Ophthalmic Emulsion had a 191% increase in average globlet cell density from baseline, while the vehicle arm increased only 13% by Month 6
In a survey of 3,127 patients, satisfaction was best for those RESTASIS® Ophthalmic Emulsion patients who were fully compliant with therapy.3
References
- Sall K, Stevenson OD, Mundorf TK, Reis BL, and the CsA Phase 3 Study Group. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. Ophthalmology. 2000;107:631-639.
- Kunert KS, Tisdale AS, Stern ME, et al. Effect of cyclosporine ophthalmic emulsion on the number of inflammatory cells and globlet cells in conjunctival biopsies of patients with dry eye. Invest Ophthalmol Vis Sci. 1999;40:S771.
- Trattler W, Katsnev D,l Kerney D. Self-reported compliance with topical cyclosporine emulsion 0.05% and onset of effects of increased tear production. Presented at: ARVO Annual Meeting: April 30-May 4, 2006; Ft. Lauderdale, Fla.
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RESTASIS® Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Important Safety Information:
RESTASIS® is contraindicated in patients with active ocular infections and has not been studied in patients with a history of herpes keratitis.
The most common adverse event was ocular burning (upon instillation) – 17%. Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
Please see full prescribing information for RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%.