Purpose:
To evaluate the tolerability and IOP-lowering efficacy of travoprost BAK free (TZ), in primary open angle glaucoma or ocular hypertension patients previously using prostaglandin monotherapy.
Methods:
A prospective, 3-month, multi-center, open-label, historical controlled study in glaucoma patients previously treated with latanoprost or bimatoprost needing improved tolerability. At Visit 1, anterior segment symptoms were evaluated by the validated Ocular Surface Disease Index (OSDI) and baseline IOP and hyperemia were measured prior to starting TZ. At 3 months, patients were re-evaluated.
Results:
690 patients completed this study. TZ demonstrated statistically improved overall mean OSDI scores (9.0±11.0) versus latanoprost (12.4±13.3, P<0.0001) and versus bimatoprost (13.5±14.7, P<0.0001). The table below represents the OSDI score change based on original OSDI group assignment.Questions which were improved on TZ, with a Bonferroni correction, were: sensitivity to light, grittiness, pain, blurred or poor vision, and difficulties with: reading, driving at night, computer work, windy conditions and low humidity (P≤0.0007). Visual acuity improved on TZ to 0.163 ± 0.135 vs. 0.169 ± 0.141 on prior therapy (P=0.02). Patients on TZ experienced less conjunctival hyperemia (0.5±0.6) than those on latanoprost (0.7±0.7, P<0.0001) or bimatoprost (1.0±0.9, P<0.0001). Global patient preference results revealed that 499 patients (72%) preferred TZ (P=0.01). After changing from latanoprost or bimatoprost to TZ, IOP decreased from 16.7±3.5 to 16.3±3.6 mmHg (P=0.001).
Conclusions:
Patients previously treated with BAK preserved prostaglandins who changed to TZ demonstrated clinically and statistically significant reduction in symptoms of ocular surface disease. Additionally, statistically significant improvements in IOP reduction, conjunctival hyperemia, and visual acuity were observed.
Clinical Trial:
www.clinicaltrials.gov NCT00444665
Keywords: intraocular pressure • cornea: epithelium