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Pierre Huguet, Sr., Pierre Gabisson, Emmanuel Alliot, Christopher Baudouin; Safety and Efficacy Assessment of Geltim LP® 1 mg/g (Unpreserved Timolol Gel) in Ocular Hypertensive or Glaucomatous Patients Stabilized by Xalatan® with Ocular Intolerance Signs. Invest. Ophthalmol. Vis. Sci. 2011;52(14):227.
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As adverse effects of benzalkonium chloride have been well demonstrated and as no changes in intraocular pressure (IOP) were observed when patients were switched from latanoprost to timolol, this study assessed the improvement of the ocular tolerance after 3 months of Geltim LP® (unpreserved timolol 0.1%) treatment without significant change on IOP control, in patients initially treated and stabilised by monotherapy of Xalatan® (preserved latanoprost) with ocular objective intolerance.
150 patients with primary open angle glaucoma or ocular hypertension (OHT) and with local intolerance signs to Xalatan® were included in a multicentre, randomized, parallel-groups, phase IV study. Group 1 received one drop of Geltim LP® once daily in the morning and group 2 received one drop of Xalatan® once daily in the evening during 84 days. All patients attended 3 visits (D0, D28 and D84). The response to treatment was defined as a combination of the effect on IOP and on tolerance. A responder is a patient for whom the sum of the scores of the 8 ocular symptoms and the 6 objectives signs decreased by at least 20%, and for whom the effect on IOP was either satisfactory or acceptable. Primary efficacy criterion was response to treatment at D84 in the worse eye.
At D84, 91.5% of patients were responders to Geltim LP® treatment versus 48.6% under Xalatan® treatment (p<0.001). As soon as D28, 85.3% of patients responded to Geltim LP® treatment compared to 40.3% in the Xalatan® group (p<0.001). Change from baseline in IOP was not significant between treatments (p>0.05) at each assessment time and both symptoms and signs were significantly improved (p<0.001) under Geltim LP® treatment compared to Xalatan®. Furthermore, after 3 months of treatment, patients found Geltim LP® more convenient than Xalatan® (p<0.001).
Geltim LP® (without preservative) maintained the efficacy and considerably reduced signs and symptoms in almost all glaucomatous/OHT patients with intolerance signs under Xalatan® treatment which could improve patients’ compliance.
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