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HI Schenker, L Williams, SM Goode, RD Gross, JA Mathis, S Mallick, JE Dickerson, R Andrew, L Silver, T Landry; Iris Pigmentation Changes Following Treatment With Travoprost Or Latanoprost In Patients With Open-angle Glaucoma Or Ocular Hypertension . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3431.
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Purpose: To evaluate the incidence and time of onset of iris pigmentation changes following treatment of eyes with the ocular hypotensive prostaglandin analogs, Travoprost and Latanoprost. Methods: 1,679 patients enrolled in 4 phase III clinical trials for Travoprost were treated with either Travoprost 0.0015%, Travoprost 0.004% or Latanoprost 0.005%. These patients were followed for changes in iris pigmentation. Close-up macro POLAROID photographs were taken of the irides at baseline (pre-therapy), and, depending on the study, at periodic intervals for up to one year following the start of treatment. All photographs for a given patient were taken with similar lighting conditions and at the same camera exposure setting. Iris photos taken at study visits for each patient were subjectively compared with photos of the patient's irides at baseline by two independent readers. If the two readers did not agree, the photographs were evaluated by a third reader. The study was masked to the reader panel. Confirmation of a pigmentation change required agreement by 2 of the 3 readers. All patients with confirmed iris color changes were notified and asked to participate in a follow-up study in which the irides were photographed periodically for an additional 2 years. Results: Pigmentation changes were documented for 21 of 739 (2.8%) patients receiving Travoprost 0.0015%, 20 of 744 (2.7%) patients receiving Travoprost 0.004%, and 10 of 196 (5.1%) patients receiving Latanoprost. The incidence of pigmentation change varied with the baseline iris color classification. The highest incidence was found for the hazel or green (7-9%) iris classifications while the lowest incidence was found in brown (3%) or blue (<1%) irides. Of the patients who exhibited an iris pigmentation change, 37 (72.5%) were first noted at ≥ 6 months following start of therapy. Conclusion: Iris pigmentation change was observed in approximately 3% of patients receiving Travoprost (0.0015% or 0.004%) compared to approximately 5% of patients receiving Latanoprost 0.005%.
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