Efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% in patients transitioning from bimatoprost 0.03%/timolol 0.5% combination therapy

Abstract

Purpose: To determine the efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% preserved with polyquaternium-1 in patients with insufficient response to bimatoprost 0.03%/timolol 0.5% preserved with benzalkonium chloride.

Patients and methods: In this open-label nonrandomized study conducted at 13 European sites, patients with primary open-angle glaucoma or ocular hypertension with insufficient intraocular pressure (IOP) reduction during bimatoprost/timolol therapy were transitioned to travoprost/timolol (DuoTrav(®)) administered every evening for 12 weeks. Change in IOP from baseline to week 12 was assessed in patients who transitioned from fixed-combination bimatoprost/timolol (n=57, primary endpoint). Secondary assessments included change in IOP at week 4, percentage of patients with IOP ≤18 mmHg at weeks 4 and 12, change in Ocular Surface Disease Index and ocular hyperemia scores at week 12, and patient preference. Adverse events were also reported.

Results: IOP change (mean ± SD) from baseline to week 12 was -3.8±1.9 mmHg (P<0.001); results were similar at week 4. Most patients had IOP ≤18 mmHg at weeks 4 and 12 (78.6% and 85.5%, respectively). Mean Ocular Surface Disease Index score was significantly reduced (P<0.001); no significant change in ocular hyperemia score was observed (P=0.197). Treatment-related adverse events included dysgeusia, nausea, paresthesia, myalgia, headache, and eye irritation (n=1 each). Most patients (74.5%) preferred travoprost/timolol over bimatoprost/timolol.

Conclusion: Transition to travoprost/timolol significantly reduced IOP and was well tolerated in patients who had elevated IOP despite bimatoprost/timolol therapy. Polyquaternium-1-preserved travoprost/timolol was preferred over prior treatment with benzalkonium chloride-preserved bimatoprost/timolol.

Keywords: glaucoma; intraocular pressure; preservative; prostaglandin analog; β-blocker.

Figure 1

Patient disposition. Abbreviation: ITT, intent-to-treat.

Figure 2

Mean ± SD IOP at baseline and at weeks 4 and 12 in the fixed-combination bimatoprost/timolol population. Notes: Baseline data include two patients who received unfixed bimatoprost/timolol. P-values indicate significance of change from baseline. Abbreviation: IOP, intraocular pressure.

Figure 3

OSDI severity scale scores in the fixed-combination bimatoprost/timolol population at baseline and week 12; baseline data include two patients who received unfixed bimatoprost/timolol. Abbreviation: OSDI, Ocular Surface Disease Index.