Safety and efficacy of unpreserved timolol 0.1% gel in patients controlled by preserved latanoprost with signs of ocular intolerance.

Purpose: To assess the safety and efficacy of unpreserved timolol 0.1% gel in ocular hypertensive (OHT) or glaucomatous patients controlled by preserved latanoprost 0.005% but with signs of ocular intolerance.

Methods: Patients initially treated with preserved latanoprost were randomized to receive once daily either one drop of unpreserved timolol gel in the morning or one drop of preserved latanoprost in the evening for 84 days. All patients attended three visits (D0, D28 and D84). A patient was considered as responder to primary criteria at Day 84 if the sum of the scores of the eight ocular symptoms and the six objective signs had decreased by at least 20% and if the effect on intra-ocular pressure (IOP) was assessed as either satisfactory or acceptable.

Results: At D84, 91.5% of patients were responders to the primary combined efficacy/safety criteria under unpreserved timolol gel treatment versus 48.6% under preserved latanoprost treatment (P<0.001). As early as D28, 85.3% of patients were responders in the unpreserved timolol gel group compared to 40.3% of patients in the preserved latanoprost group (P<0.001). IOP change from baseline was not significant between treatments (P>0.05) at D28 or D84. Both signs and symptoms were significantly improved (P<0.001) with unpreserved timolol gel compared to preserved latanoprost.

Conclusion: Unpreserved timolol 0.1% gel maintained the efficacy of preserved latanoprost and reduced signs and symptoms of intolerance in almost all glaucomatous/OHT patients on preserved latanoprost.