Polyquaternium-1-Preserved Travoprost 0.003% or Benzalkonium Chloride-Preserved Travoprost 0.004% for Glaucoma and Ocular Hypertension.
OBJECTIVE
To demonstrate equivalence of polyquaternium-1-preserved travoprost 0.003% with benzalkonium chloride-preserved travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension.


METHODS
Double-masked, randomized, 2-treatment, equivalence clinical trial.


METHODS
setting: Multicenter clinical trial conducted in 60 centers in the United States and Europe.


METHODS
Adult patients with open-angle glaucoma or ocular hypertension. One eye per patient was analyzed.


METHODS
Patients were randomized 1:1 to receive polyquaternium-1-preserved travoprost 0.003% (n = 442) or benzalkonium chloride-preserved travoprost 0.004% (n = 422) once daily for 3 months.


METHODS
Mean intraocular pressure (IOP) was assessed at 8 AM, 10 AM, and 4 PM at week 2, week 6, and month 3. Supportive outcomes were mean and percent IOP change, percentage of patients achieving IOP <18 mm Hg or ≥30% IOP reduction, and adverse events.


RESULTS
Mean IOP was similar between groups at all study visits (travoprost 0.003% range, 17.5-18.9 mm Hg; travoprost 0.004% range, 17.4-19.0 mm Hg). Mean change (least squares mean differences, -0.1 to 0.3 mm Hg; 95% confidence interval, -0.5 to 0.7 mm Hg) and percentage change (travoprost 0.003%, 28.4%-30.7%; travoprost 0.004%, 28.5%-31.0%) from baseline were comparable. The percentages of patients with IOP <18 mm Hg and ≥30% reduction of IOP were also similar. Hyperemia was the most frequent treatment-related adverse event with both formulations (travoprost 0.003%, 11.8%; travoprost 0.004%, 14.5%).


CONCLUSIONS
In patients with open-angle glaucoma or ocular hypertension, polyquaternium-1-preserved travoprost 0.003% solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride-preserved travoprost 0.004%.
United Medical Research Institute, Inglewood, California. Electronic address: drjpeace@pacbell.net.
James H
JH
Peace
Department of Ophthalmology, Falu Hospital, Falun, Sweden.
Peter
P
Ahlberg
Grossräeschen Eye Clinic, Grossräeschen, Germany.
Mathias
M
Wagner
Houston Eye Associates, Houston, Texas.
John M
JM
Lim
Eye Research Foundation, Newport Beach, California.
David
D
Wirta
Private Practice, Winston-Salem, North Carolina.
James D
JD
Branch
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage; D001548:Benzalkonium Compounds / Q000008:administration & dosage*; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011108:Polymers / Q000008:administration & dosage*; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage; D012189:Retrospective Studies; D014065:Tonometry, Ocular; D000069557:Travoprost; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011108:Polymers; D011310:Preservatives, Pharmaceutical; D003008:Cloprostenol; C058655:polyquaternium 1; D000069557:Travoprost