Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

Abstract

BackgroundProspective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC) for ≥18 months using a prospective, observational design.MethodsIn all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP), visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP) population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24.ResultsOf the 2339 subjects switched to latanoprost/timolol FC (safety population), the primary reasons for switching were inadequate IOP reduction (78.2%) and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible). In all, 1317 (56.3%) subjects completed the study, and 1028 (44.0%) were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P < 0.05 for change at all time points). By investigator assessments, optic disc parameters and visual field were stable over 24 months, and there was no relationship between IOP reduction over 24 months and development of a visual field defect. More than 90% of physicians rated latanoprost/timolol FC as "very good" or "good" for efficacy (PP population), tolerability, and compliance. The FC was safe and well tolerated. No change in iris color was reported by most subjects (83.1%) at month 24.ConclusionsOver 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up.

Efficacy and safety of switching to latanoprost 0.005%&ndash;timolol maleate 0.5% fixed-combination eyedrops from an unfixed combination for 36 months

“…Numerous studies4–9 have reported a lack of serious adverse reactions, which is consistent with our findings in this study. Moreover, in the metaanalysis, the fixed-combination eyedrops were associated with a lower risk of hyperemia than the concomitantly used eyedrops 8.…”

Comparative Effect of Latanoprost/Timolol Fixed Combination and Unfixed Combination in Patients with Ocular Hypertension Attending Irrua Specialist Teaching Hospital, Irrua, Nigeria

“…This is evident in the observed IOP lowering effect and unrecorded adverse outcomes in our study population. This finding is in accordance with the reports of several prospective and randomized clinical trials where the combinations of latanoprost/timolol havedemonstrated effectiveness and tolerability [17][18][19][20][21][22][23].…”

A Randomised Open Label Comparative Clinical Trial on the Efficacy of Latanoprost and Timolol in Primary Open Angle Glaucoma

“…Previous research has demonstrated that progression of glaucoma or ocular hypertension can be delayed or halted by lowering IOP levels through the use of ocular hypotensive agents [14].…”