RESUMEN
GOALS: To assess the efficacy and safety of preservative-free timolol 0.1% gel in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT). METHODS: In this multicenter, open-label, non-controlled clinical trial in Algeria, treatment-naïve patients with intraocular pressure (IOP)>20mmHg and<31mmHg (treatment-naïve patients, group 1) and patients with IOP controlled by current ocular monotherapy but presenting with local intolerance in at least one eye (intolerant patients; group 2) were eligible. Timolol gel was administered once daily in the morning for 84 days. The primary efficacy criteria were reduction in IOP (group 1) and maintenance of baseline IOP (group 2). RESULTS: Overall, 93 patients were included (53 in group 1, 40 in group 2). All patients in group 2 had been previously treated with preserved eye drops. In group 1, patients showed a significant reduction in IOP with mean changes in the worse eye of -10.3±3.0mmHg at D28 and -10.8±2.5mmHg at D84 (P<0.0001). In group 2, the maintenance of efficacy on IOP at D84 was satisfactory in 91.7% of patients (worse eye). Preservative-free timolol gel was well tolerated in both groups. In group 2, the overall symptom score was significantly reduced from 8.6±5.1 to 0.9±1.6 at D28 and 0.7±1.2 at D84 (P<0.0001), and the overall ocular sign score from 3.7±2.1 to 0.8±1.0 at D28 and 0.6±0.8 at D84 (P<0.0001). CONCLUSIONS: This preservative-free timolol 0.1% gel was effective in decreasing IOP in treatment-naïve patients and in controlling IOP and reducing ocular signs and symptoms in patients intolerant to their previous preserved medications.