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Abstract #16897 Published in IGR 9-1
Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy
Lewis RA; Katz GJ; Weiss MJ; Landry TA; Dickerson JE; James JE; Hua SY; Sullivan EK; Montgomery DB; Wells DTJournal of Glaucoma 2007; 16: 98-103
See also comment(s) by David Broadway •
PURPOSE: To compare the safety and efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. METHODS: The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either travoprost 0.004% with BAC (n = 346), or travoprost 0.004% without BAC (n = 344) dosed once-daily each evening. 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: Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mmHg for travoprost 0.004% without BAC and from 7.4 to 8.4 mmHg for travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were 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 owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with travoprost 0.004% without BAC and travoprost 0.004% with BAC, respectively. CONCLUSION: Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.
Dr. R.A. Lewis, Grutzmacher and Lewis, Inc, Sacramento, CA, USA
Classification:
11.16 Vehicles, delivery systems, pharmacokinetics, formulation (Part of: 11 Medical treatment)
11.4 Prostaglandins (Part of: 11 Medical treatment)
