The purpose of the study is to provide evidence that the efficacy of Xalatan will be superior to Apo-latanoprost and Co-latanoprost in the reduction of intraocular pressure in patients with primary open angle glaucoma. The study will also aim to prove the tolerability of Xalatan in terms of ocular hyperemia will be equivalent to its generic counterparts.
Since the introduction of Xalatan generic versions of latanoprost have entered the Canadian marketplace such as Apo-latanoprost (Apotex Inc.), Co-latanoprost (Cobalt Pharmaceuticals Co.) and Sandoz latanoprost (Sandoz Canada Inc.). The exact formulation of the different preparations of latanoprost may differ between manufacturers, although the active ingredient itself is not supposed to vary within a 15% tolerance. In a topical ocular medication in a multi-dose dispenser, the stability of the drug and its ability to penetrate the cornea into the eye may affect the efficacy of the drug. There are no clinical trials to compare the efficacy of generic versions of latanoprost to Xalatan, nor are there any clinical trials comparing efficacy between the different generic versions. Empirical evidence based on clinical experience suggests that at least some of the generic versions of latanoprost may not be as effective as the branded version (Xalatan). Intraocular pressure is often observed to increase when switching from a branded to generic version of latanoprost, but the opposite is rarely if ever observed. The purpose of this study will be to compare the efficacy of Xalatan to two of the most popular generic versions of latanoprost available in Canada (Apo-latanoprost and Co-latanoprost).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
Opthalmis Diagnostic Services
Toronto, Ontario, Canada
RECRUITINGIntraocular Pressure
Pressure within the eye will be measured at each study visit.
Time frame: 4 weeks
Ocular Hyperemia
Redness of the cornea will be quantified at each study visit using the Efron scale. The scale reads 0-5, 5 being the highest level of ocular hyperemia.
Time frame: 4 weeks
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