Travoprost 0.004% timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled-masked comparison of safety and efficacy

• Published in: Eye (London) Vol. 25; no. 9; pp. 1161 - 1169
• Main Authors: Kitazawa, Y, Smith, P, Sasaki, N, Kotake, S, Bae, K, Iwamoto, Y
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.09.2011; Nature Publishing Group
• Subjects: 631/92/436/108; 692/699; Aged; Antihypertensive Agents - adverse effects; Antihypertensive Agents - therapeutic use; Benzalkonium Compounds - therapeutic use; Biological and medical sciences; Clinical Study; Cloprostenol - adverse effects; Cloprostenol - analogs & derivatives; Cloprostenol - therapeutic use; Double-Blind Method; Drug Therapy, Combination - methods; Female; Glaucoma and intraocular pressure; Glaucoma, Open-Angle - drug therapy; Glaucoma, Open-Angle - physiopathology; Humans; Intraocular Pressure - drug effects; Japan; Laboratory Medicine; Logistic Models; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Miscellaneous; Ocular Hypertension - drug therapy; Ocular Hypertension - physiopathology; Ophthalmology; Pharmaceutical Sciences/Technology; Polymers - therapeutic use; Prospective Studies; Surgery; Surgical Oncology; Timolol - adverse effects; Timolol - therapeutic use; Travoprost; United States; United States; Japan; timolol; travoprost; benzalkonium chloride; prostaglandin analogs; intraocular pressure; glaucoma; Antiglaucomatous agent; Glaucoma; Toxicity; Benzalkonium chloride; β-Adrenergic receptor; Prospective; Glaucoma (eye); Antagonist; Ophthalmology; Safety; Timolol; Travoprost; Hormone; Protozoa; Prostaglandin; Mask; Quaternary ammonium compound; Eye disease; Analog; Antiseptic; Ciliata; Disinfecting agent; Comparative study; Beta blocking agent; Prostaglandin derivatives; Intraocular pressure
• ISSN: 0950-222X; 1476-5454
• DOI: 10.1038/eye.2011.134

Purpose The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension. Methods In this prospective randomized controlled trial, subjects with IOP of at least 22 mm Hg in one or both eyes at 0900 h, and IOP of at least 21 mm Hg in one or both eyes at 1100 h and 1600 h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free ( n =195) or TRA/TIM ( n =193), dosed once daily in the morning (0900 h) for 6 weeks. IOP was assessed at 0900 h, 1100 h, and 1600 h at each scheduled visit (baseline, 2 and 6 weeks after randomization). Results Mean IOP reduction across all visits and time points was 8.0 mm Hg in the TRA/TIM BAK-free group and 8.4 mm Hg in the TRA/TIM group ( P =0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7 mm Hg across visits and time points, with a mean pooled difference of 0.4 mm Hg (95% CI: −0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group. Conclusion Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified.