Travoprost 0.004% With and Without Benzalkonium Chloride: A Comparison of Safety and Efficacy

Abstract

Purpose: : The safety and efficacy of a new formulation of travoprost 0.004% without benzalkonium chloride (travoprost BAC–free) was compared to that of the marketed formulation of travoprost 0.004% (TRAVATAN®) in patients with open–angle glaucoma (OAG) or ocular hypertension (OHT).

Methods: : The study was a double–masked, randomized, parallel group, multicenter, non–inferiority design. Adult patients with OAG or OHT and with qualifying IOP (24 to 36 mm Hg at 8 AM; 21 to 36 mm Hg at 10 AM and 4 PM following appropriate washout of previous ocular hypotensives) in at least one eye on two eligibility visits received either travoprost 0.004% preserved with BAC (n = 346) or travoprost BAC–free (n = 344) dosed once–daily each evening. Study patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM and 4 PM were taken at study visits on week 2, week 6, and month 3.

Results: : The 95% confidence limits for the difference in mean IOP were within +/– 0.8 mmHg at 9 of 9 study visits and times in both the per protocol and intent–to–treat data sets. Mean IOP reductions, across all 9 study visits and times in both the per protocol and intent–to–treat data sets, ranged from 7.3 to 8.5 mmHg for travoprost BAC–free and from 7.4 to 8.4 mmHg for travoprost 0.004%. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits are within +/– 0.8 mmHg at 9 of 9 study visits and times in both the per protocol and intent–to–treat data sets. Adverse events and the number of patients discontinued due to adverse events were similar for both treatment groups. 6.4% of patients treated with travoprost BAC–free experienced an adverse event due to hyperemia.

Conclusions: : Travoprost BAC–free is equivalent to travoprost 0.004% in both safety and efficacy.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials