Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma

Abstract

Preservative-free latanoprost has the same efficacy as BPL, with improved local tolerance.

Preservative-free versus preserved latanoprost eye drops in patients with open-angle glaucoma or ocular hypertension

“…The present study evaluated IOP efficacy data throughout the day compared to the single time point analysis in the phase III study. The data in the present study show the diurnal IOPlowering behavior of the preservative-free formulation, which was similar to that for the preserved formulation, and supported the optimization of the timing for the IOP assessment in the confirmatory phase III study 20 . Since the early morning time point in the present study was shown to be the most challenging time to demonstrate non-inferiority of the preservative-free to the preserved formulation, it was decided to conduct the IOP assessment during that time in the phase III study, this time point being strongly representative of the IOP-lowering effect in the afternoon.…”

“…Despite the small sample size in the present study, this data is aligned with the demonstration of non-inferiority in the pivotal phase III study 20 . In addition, the data from the present study demonstrate excellent diurnal control of IOP by both preservative-free and preserved latanoprost.…”

“…This phase II study, conducted to evaluate the diurnal efficacy, safety, and pharmacokinetics of a preservative-free latanoprost eye drop formulation, adds to the existing body of data describing this formulation, notably the phase III data 20 . The present study evaluated IOP efficacy data throughout the day compared to the single time point analysis in the phase III study.…”

“…There was no significant difference in the reduction of IOP between treatments at any time point, with the upper 95% CI being less than 1.5 mmHg for each comparison (this being an accepted limit for non-inferiority used in similar studies 20 ) and all 95% CIs of the difference containing the 0 value. The biggest difference was at 08:00, with absolute IOP values of 16.2 ± 2.9 mmHg (preserved) versus 16.6 ± 2.2 mmHg (preservative-free) and a difference of 0.5 ± 2.5 mmHg between treatments, but the 95% CI contained the 0 value and the upper 95% CI for the difference remained <1.5 mmHg (1.49 mmHg) 20 .…”

“…In this study, however, there was no difference in tolerance between the groups, which may reflect the short treatment period (42 days) in this study and the small number of patients. In the phase III study, a 3 month treatment period was investigated and clear differences in tolerance were evident -moderate to severe conjunctival hyperemia was less frequent for the preservative-free formulation and upon instillation the global subjective ocular symptom score was lower for the preservative-free formulation 20 . In an overall assessment of the benefit of the preservative-free formulation this improved tolerance in chronic use with maintained efficacy is a key issue.…”