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.
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.
Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg 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 mm Hg 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.
Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.
*Grutzmacher and Lewis, Inc, Sacramento, CA
†Huron Ophthalmology, Ypsilanti, MI
‡The Eye Institute, Tulsa, OK
§Alcon Research, Ltd, Fort Worth, TX
Support for this study was provided by Alcon Research, Ltd, Fort Worth, TX.
Reprints: Jaime E. Dickerson, PhD, Alcon Research, Ltd., Fort Worth, TX (e-mail: email@example.com).
Received for publication May 2, 2006; accepted July 19, 2006