Abstract
Purpose :
To compare the effect on IOP and safety of unpreserved fixed combination latanoprost-timolol (T2347) to established benzalkonium chloride (BAK)-preserved latanoprost-timolol (BPLT, Xalacom®) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
Methods :
Phase III, randomised, parallel-group, investigator-masked study conducted in 10 countries. Male or female patients aged ≥18 years with OAG or OHT in both eyes controlled with BPLT were randomised at Day 0 (D0) to receive T2347 (N=127) or BPLT (N=115) each evening for 84 days. Efficacy on intraocular pressure (IOP) was measured in the morning of D0, D42, and D84, and non-inferiority of T2347 to BPLT was tested statistically based on the change in IOP from D0 to D84. Safety parameters were also reported.
Results :
The mean change in IOP from baseline to D84 was -0.49±1.80 mmHg for preservative-free T2347 and -0.49±2.25 mmHg for preserved BPLT. These results met the limits set for non-inferiority. Similar results were observed at D42. T2347 was better tolerated than BPLT in terms of ocular irritation/burning/stinging on instillation on D42 (p=0.003) and D84 (p<0.001), and itching on D84 (p=0.010). Itching throughout the day was also less severe for T2347 than BPLT on D84 (p<0.001).
Conclusions :
Preservative-free fixed combination latanoprost-timolol formulation showed similar efficacy and better tolerability than BPLT, suggestive of a therapeutic advantage of the preservative-free formulation for chronic use in patients with OAG/OHT.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.