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D. Eveleth, D.A. Paggiarino; Interim Results of a Randomized, Open–label Safety Study Comparing Latanoprost to Usual Care in Patients with Open–angle Glaucoma or Ocular Hypertension . Invest. Ophthalmol. Vis. Sci. 2004;45(13):5571.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To report 3–year findings of a 5–year postmarketing surveillance study of adverse events associated with latanoprost 0.005% versus usual care. Methods: In this multinational, open–label, safety study, latanoprost–naive patients with open–angle glaucoma or ocular hypertension who required a change in therapy were randomly assigned (2:1) to latanoprost administered once daily or to usual care. Investigators selected usual care therapy and could modify the therapy of any patient in either randomization group if intraocular pressure (IOP) was not sufficiently controlled. All patients were examined at baseline and every 6 months. Patients randomized or switched to latanoprost had iris photography prior to initiating latanoprost and at all subsequent visits. The main safety endpoints were the occurrence of serious adverse events, serious adverse drug reactions, and changes in pigmentation or eyelashes. Results: The randomized population included 5848 patients (latanoprost, 3933; usual care, 1915); 4691 patients received latanoprost at some time during the study. IOP levels were reduced from baseline in both randomized groups. New occurrences of corneal erosions, iritis/uveitis, or macular edema were seen in <2.3% of patients in either randomization group. Serious adverse drug reactions were reported in 14 patients (0.36%) randomized to latanoprost and 6 (0.31%) randomized to usual care; 3 usual care patients also received latanoprost, yielding 17 serious adverse drug reactions for the total latanoprost population (0.36%). In the total latanoprost population, 10 patients (0.21%) discontinued treatment due to a serious adverse drug reaction and 3 (0.06%) discontinued the study. Investigators judged that <10% of the latanoprost population had increased pigmentation of the iris or periorbital skin, while about 35% had eyelash changes; most (>85%) changes occurred within the first 24 months. None of the 17 patients with serious adverse drug reactions had increased iris pigmentation. Conclusion: Latanoprost is safe over 3–years of treatment with no evidence of possible long–term consequences of increased iris pigmentation. December 1, 2003
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