A phase 2, randomized study evaluating the safety and efficacy of Catioprost® (unpreserved latanoprost 0.005% emulsion) compared to Travatan Z® in subjects with glaucoma and ocular surface disease

Authors


Abstract

Purpose Ocular Surface Disease (OSD), recognized in 50% of glaucoma patients, can decrease anti-glaucoma therapy compliance. Benzalkonium chloride (BAK) has been shown to induce OSD. Catioprost® is an unpreserved latanoprost 0.005% cationic emulsion. The design of a study comparing the efficacy and safety of Catioprost® versus a BAK-free prostaglandin agonist, Travatan Z® (travoprost 0.004%) in patients with glaucoma and OSD is described.

Methods Patients with elevated IOP at baseline requiring treatment with ocular anti-hypertensive therapy were enrolled in this multicenter, phase II, investigator-masked, randomized study. Following a washout period, patients demonstrating OSD symptoms and signs (corneal fluorescein staining, CFS, score≥1 on the modified Oxford scale and a tear film break up time, TFBUT, ≤10) in at least one eye at the baseline visit were randomized to either Catioprost® or Travatan Z® QD with follow-up study evaluations at month 1 and 3.

Results 105 patients were randomized. Change in diurnal IOP, a change in the global symptoms (ocular discomfort, burning, dryness, grittiness, stinging) and objective signs (CFS, TFBUT, conjunctival hyperemia) of OSD at month 1 and 3 will be presented. Safety outcomes will also be reported.

Conclusion Preservative free prostaglandin agonists reduce the risk of ocular toxicity associated with BAK. However, their effect on restoring ocular surface damage is unclear. In this study, the efficacy and safety of an unpreserved latanoprost 0.005% cationic emulsion relative to BAK-free travoprost 0.004% solution on reducing IOP and improving the signs and symptoms of OSD will be revealed.

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