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Clinical Trials
July 2004

A 5-Year, Multicenter, Open-Label, Safety Study of Adjunctive LatanoprostTherapy for Glaucoma

Author Affiliations

From Department of Neuroscience, Ophthalmology, University Hospital,Uppsala, Sweden (Dr Alm); and Pharmacia Ltd, London, England (Drs Schoenfelderand McDermott). The authors have no relevant financial interest in this article.

Arch Ophthalmol. 2004;122(7):957-965. doi:10.1001/archopht.122.7.957

Objective  To evaluate the 5-year safety and efficacy of adjunctive 0.005% latanoprostonce daily.

Methods  Patients with primary open-angle or exfoliation glaucoma who completeda 3-year, open-label, uncontrolled, prospective trial could enter a 2-yearextension phase. High-resolution color photographs of irides were taken atbaseline and at 14 subsequent visits. Photographs were assessed for changein iris pigmentation compared with baseline. Intraocular pressures and adverseevents were recorded.

Main Outcome Measure  Development and progression of increased iris pigmentation over 5 years.

Results  Of the 519 original patients, 380 enrolled in the extension phase withapproximately 89% having an eye color known to be susceptible to color change.After 5 years, most patients had no increase in iris pigmentation, but certaincolored irides exhibited notably greater susceptibility than others. For thosewhose irides did change, onset occurred during the first 8 months in 74% andduring the first 24 months in 94%. No patient developed an increase in pigmentationafter month 36; the rate of progression decreased over time. Adverse eventprofiles were similar for patients with and without increased pigmentation.The overall mean intraocular pressure reduction from baseline of 25% was sustainedwith no need for change in intraocular pressure–lowering treatment in70% of the eyes.

Conclusion  Latanoprost therapy is safe and well tolerated for long-term treatmentof open-angle glaucoma.