Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy.

Abstract

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 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.

CONCLUSION:

Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.

• Authors: Richard A Lewis, Gregory J Katz, Mark J Weiss, Theresa A Landry, Jaime E Dickerson, John E James, Steven Y Hua, E Kenneth Sullivan, Dawnelle B Montgomery, David T Wells, Michael V W Bergamini, Travoprost BAC-free Study Group
• Journal: Journal of glaucoma (J Glaucoma) Vol. 16 Issue 1 Pg. 98-103 (Jan 2007) ISSN: 1057-0829 [Print] United States
• PMID: 17224758 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Benzalkonium Compounds
• Ophthalmic Solutions
• Preservatives, Pharmaceutical
• Cloprostenol
• Travoprost

Topics

• Aged
• Antihypertensive Agents (administration & dosage, adverse effects, therapeutic use)
• Benzalkonium Compounds (administration & dosage, adverse effects, therapeutic use)
• Chemistry, Pharmaceutical
• Cloprostenol (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Double-Blind Method
• Female
• Glaucoma, Open-Angle (drug therapy)
• Gonioscopy
• Humans
• Intraocular Pressure (drug effects)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy)
• Ophthalmic Solutions (administration & dosage, adverse effects, therapeutic use)
• Preservatives, Pharmaceutical (administration & dosage, adverse effects, therapeutic use)
• Tonometry, Ocular
• Travoprost
• Treatment Outcome