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Am J Ophthalmol. 2015 Aug;160(2):266-274.e1. doi: 10.1016/j.ajo.2015.04.041. Epub 2015 Apr 30.

Polyquaternium-1-Preserved Travoprost 0.003% or Benzalkonium Chloride-Preserved Travoprost 0.004% for Glaucoma and Ocular Hypertension.

Author information

1
United Medical Research Institute, Inglewood, California. Electronic address: drjpeace@pacbell.net.
2
Department of Ophthalmology, Falu Hospital, Falun, Sweden.
3
Grossräeschen Eye Clinic, Grossräeschen, Germany.
4
Houston Eye Associates, Houston, Texas.
5
Eye Research Foundation, Newport Beach, California.
6
Private Practice, Winston-Salem, North Carolina.

Abstract

PURPOSE:

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.

DESIGN:

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

METHODS:

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

PATIENT POPULATION:

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

INTERVENTION:

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.

MAIN OUTCOME MEASURES:

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%.

PMID:
25935098
DOI:
10.1016/j.ajo.2015.04.041
[Indexed for MEDLINE]
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