Safety and efficacy of fixed-combination travoprost/timolol in patients with open-angle glaucoma or ocular hypertension not controlled with timolol monotherapy

Abstract

Marcelo Lopes da Silva Jordão,1 Marcelo Hatanaka,2 Abayomi Ogundele,3 Maria Rosa Bet de Moraes Silva,4 Roberto Murad Vessani5 1Faculty of Medicine of Ribeirão Preto, University of São Paulo, São Paulo, Brazil; 2University of São Paulo School of Medicine, São Paulo, Brazil; 3Global Medical Affairs, Alcon Laboratories, Inc., Fort Worth, TX, USA; 4Faculty of Medicine of Botucatu, Universidade Estadual Paulista (UNESP), São Paulo, Brazil; 5General Hospital of Itapecerica da Serra, Serviço Social da Construção Civil do Estado de São Paulo (SECONCI-SP) São Paulo, Brazil Objective: To assess the intraocular pressure (IOP)-lowering effect of travoprost 0.004%/timolol 0.5% fixed-dose combination (TRAV/TIM–FC) in patients not achieving the target IOP of ≤18 mmHg while on timolol 0.5% (TIM) monotherapy. Methods: A multicenter, prospective, open-label study (NCT01336569) was conducted in patients with open-angle glaucoma or ocular hypertension. Eligible patients were receiving TIM monotherapy with a screening/baseline IOP of 19–35 mmHg in ≥1 eye. TIM was discontinued on the baseline visit day (no washout period) and TRAV/TIM–FC was initiated and administered once daily at 8 pm for 4–6 weeks. The primary efficacy variable was mean change in IOP from TIM-treated baseline to study end, measured by Goldmann applanation tonometry. Results were analyzed by analysis of variance and paired samples t-test (5% significance). Results: A total of 49 patients were enrolled (mean age, 63 [range, 42–82] years; 55.1% White; 73.5% women), and 45 were included in the intent-to-treat (ITT) population. Mean duration of treatment with TRAV/TIM–FC was 31 days. Mean ± standard deviation IOP reduction from baseline (TIM) to the follow-up visit (TRAV/TIM–FC) was -5.0±3.6 mmHg. IOP decreased significantly (P<0.0001) from baseline (22.1±2.6 mmHg) to study end (17.1±3.9 mmHg) in the ITT population, with a mean IOP reduction of 22.3%. Most patients (n=33/45; 73.3%) achieved IOP ≤18 mmHg. Two patients experienced a total of four adverse events (AEs), including a patient who reported one serious AE (enterorrhagia) that was considered unrelated to treatment, and a patient who reported one event each of drug-related redness, pruritus, and foreign body sensation. Most patients (n=47/49; 95.9%) reported no AEs. Conclusions: TRAV/TIM–FC lowered IOP in patients who were not at target IOP while receiving TIM monotherapy, with most patients achieving an IOP ≤18 mmHg with TRAV/TIM–FC. TRAV/TIM–FC was well tolerated in this population.  Keywords: DuoTrav®, intraocular pressure, primary open-angle glaucoma, time since diagnosis