Multicenter, open-label evaluation of hyperemia associated with use of bimatoprost in adults with open-angle glaucoma or ocular hypertension.

This month-long multicenter, open-label study evaluated the onset and progression of hyperemia associated with bimatoprost 0.03% once daily in 39 patients with open-angle glaucoma or ocular hypertension. Current glaucoma medication(s) was either replaced with or augmented by bimatoprost. Previous users of bimatoprost were excluded. Primary outcome measures were mean hyperemia scale scores (ciliary, conjunctival, and episcleral, graded on a seven-point scale) and incidence of hyperemia. Secondary outcome measures were fluorescein staining, patient assessment of ocular redness (take-home diary), and patient and investigator evaluations. Patients were asked how troubled they were by their ocular redness. Investigators were asked if they would continue the patient on bimatoprost despite the hyperemia. Overall, the frequency and severity of hyperemia peaked approximately 1 day after the first instillation of bimatoprost and decreased consistently throughout the study, returning to near-baseline levels by day 28. At day 1, 84.6% of patients were hardly troubled or not troubled by their ocular redness; only 15.4% were somewhat or moderately troubled. Investigators indicated that they would continue bimatoprost therapy in 92.3% of the patients. Hyperemia did not represent a significant safety concern.