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G. J. Katz, C. L. Springs, E. R. Craven, M. Montecchi-Palmer; Double-Masked, Randomized, Multi-Center, Examination of Ocular Surface Disease in Glaucoma Patients on Latanoprost With Benzalkonium Chloride (BAK) versus Travoprost BAK-Free. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6445.
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To quantify changes in symptoms of ocular surface disease (OSD) using the ocular surface disease index (OSDI©) after randomizing glaucoma patients currently on latanoprost with 0.02% BAK (LAT) to either remain on LAT or change to travoprost BAK-free (TRAV).
This was a 12 week double-masked, multi-center, randomized controlled trial. Patients (n = 724) on LAT monotherapy were randomized to either LAT or TRAV monotherapy. All patients were required to have baseline OSDI scores ≥ 13.
Of the 724 patients enrolled, 674 were evaluable for the intent to treat (ITT) analysis. Baseline OSDI scores were: Mild = 277, Mod = 176, Severe = 221. TRAV patients who scored mild at baseline performed significantly better (mean of 16.6 improving to 11.6) (5 point improvement) than those patients on LAT (17.2 improving to 14.4) (2.7 point improvement) at the Month 3 visit (for mean differences at Month 3, p = 0.0436). A higher percent of patients on TRAV returned to a normal OSDI (62.9%) compared to those patients on LAT (47.0%, p = 0.0085). In the moderate and severe groups, the mean differences between TRAV and LAT were not statistically significant at Month 3. An examination of the length of time on LAT prior to the start of the study, regardless of starting OSDI severity, demonstrated statistically significant differences in the >24 months subset for the percent of patients returning to a normal OSDI at Month 3 (p = 0.0314).
Patients with mild OSD symptom scores randomized to TRAV demonstrated clinically and statistically significant improvement in symptoms of OSD compared to patients remaining on LAT with BAK. Improvement of OSD symptoms is observed in all groups when analyzing patients with pre-study LAT exposure of > 24 months. Additional studies are needed to examine study duration and other possible physiological factors contributing to the level of severity in moderate/severe patients to better understand the impact of changing to a BAK-free medication.
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