Incidence of a Latanoprost-Induced Increase in Iris Pigmentation in Japanese Eyes

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doi:10.1007/s10384-005-0288-7

Cited by 12 publications

(3 citation statements)

References 10 publications

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“…In the current study, iris hyperpigmentation was reported as an AE in 4% of treated eyes, and, at 1 year, an increase in iris pigmentation was noted in 9% of treated eyes and a possible increase was noted in another 14% based on iris photographs. Iridial pigmentation changes have also been reported with latanoprost in clinical studies with Japanese subjects [ 40 – 43 ]. These studies found the incidence of iris pigmentation to increase in proportion to duration of latanoprost treatment, with reported frequencies at 1 year ranging from 51.6% [ 42 ] to 58.2% [ 43 ] based on slit-lamp biomicroscopy, a rate much higher than that found in the current study with LBN.…”

Section: Discussionmentioning

confidence: 90%

“…Iridial pigmentation changes have also been reported with latanoprost in clinical studies with Japanese subjects [ 40 – 43 ]. These studies found the incidence of iris pigmentation to increase in proportion to duration of latanoprost treatment, with reported frequencies at 1 year ranging from 51.6% [ 42 ] to 58.2% [ 43 ] based on slit-lamp biomicroscopy, a rate much higher than that found in the current study with LBN. However, another 1-year study of latanoprost in 124 Japanese patients with primary OAG or OHT reported iris hyperpigmentation in only ten patients [ 44 ].…”

Section: Discussionmentioning

confidence: 90%

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Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study

et al. 2016

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IntroductionLatanoprostene bunod (LBN) is a novel nitric oxide (NO)-donating prostaglandin F2α analog. We evaluated the long-term safety and intraocular pressure (IOP)-lowering efficacy of LBN ophthalmic solution 0.024% over 1 year in Japanese subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).MethodsThis was a single-arm, multicenter, open-label, clinical study. Subjects aged 20 years and older with a diagnosis of OAG or OHT instilled 1 drop of LBN ophthalmic solution 0.024% in the affected eye(s) once daily in the evening for 52 weeks and were evaluated every 4 weeks. Safety assessments included vital signs, comprehensive ophthalmic exams, and treatment-emergent adverse events (AEs). Absolute and percent reductions from baseline in IOP were also determined.ResultsOf 130 subjects enrolled, 121 (93.1%) completed the study. Mean age was 62.5 years, and mean (standard deviation) baseline IOP was 19.6 (2.9) and 18.7 (2.6) mmHg in study eyes and treated fellow eyes, respectively. Overall, 76/130 (58.5%) and 78/126 (61.9%) subjects experienced ≥1 AEs in study eyes and treated fellow eyes, respectively. In both study eyes and treated fellow eyes, the most common AEs were conjunctival hyperemia, growth of eyelashes, eye irritation, and eye pain. At 52 weeks, 9% of treated eyes had an increase in iris pigmentation compared with baseline based on iris photographs. No safety concerns emerged based on vital signs or other ocular assessments. Mean reductions from baseline in IOP of 22.0% and 19.5% were achieved by week 4 in study and treated fellow eyes, respectively. These reductions were maintained through week 52 (P < 0.001 vs. baseline at all visits).ConclusionOnce daily LBN ophthalmic solution 0.024% was safe and well-tolerated in Japanese subjects with OAG or OHT when used for up to 1 year. Long-term treatment with LBN ophthalmic solution 0.024% provided significant and sustained IOP reduction.Trial registrationClinicalTrials.gov identifier, NCT01895972.FundingBausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 90%

Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study

et al. 2016

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“…In this study we evaluated iris pigmentation objectively as 50.0%, which might be more frequent than that in the previous studies 2–5. On the other hand, iris pigmentation induced by latanoprost treatment evaluated objectively has been reported as 16.3%, 34.2%, 49.2%, 58.2%, and 58.2% at 6, 9, 9, 12, and 15 months after the start of latanoprost treatment 10. Frequency rates rose as progression occurred.…”

Section: Discussionmentioning

confidence: 80%

Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension

Inoue¹,

Shiokawa²,

Sugahara³

et al. 2012

OPTH

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PurposeTo prospectively investigate adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. We also examined patient attitudes to adverse reactions via a questionnaire.MethodsFifty-two Japanese patients with glaucoma or ocular hypertension were enrolled. Iridial, eyelid, and eyelash photographs were taken before and at 6 months after bimatoprost treatment. Increase in eyelid pigmentation, iridial pigmentation, eyelash growth and bristle, and vellus hair of the lid was assessed from the photographs. Questionnaires completed by patients provided insight into their subjective judgment of adverse reactions.ResultsIncrease in eyelash bristle (53.8%), iris pigmentation (50.0%), eyelash growth (46.2%), vellus hair of the lid (40.4%), and eyelid pigmentation (7.7%) was evident after bimatoprost treatment. The objective and subjective assessments were in agreement in terms of increase in eyelash bristle, eyelash growth, and increase in vellus hair of the lid.ConclusionMost patients were conscious of these adverse reactions. Before administering bimatoprost, sufficient explanation of potential adverse reactions should be provided; after initiating treatment, careful observation is required.

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Eyelid and eyelash changes due to prostaglandin analog therapy in unilateral treatment cases

et al. 2012

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Incidence of a Latanoprost-Induced Increase in Iris Pigmentation in Japanese Eyes

Abstract: Latanoprost instillation for at least 1 year induced increased iris pigmentation in approximately 50% of the treated Japanese eyes, which is a considerably higher percentage than that reported in Caucasians.

Cited by 12 publications

References 10 publications

Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study

Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study

Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension

Eyelid and eyelash changes due to prostaglandin analog therapy in unilateral treatment cases

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