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Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypkertension. In the four clinical trials, patients were treated with Isopto® Carpine 2%, two to four times daily or with pilocarpine 1%, 1.75% or 2% in fixed combination with betaxolol 0.25%, two or three times daily.

The most frequently reported adverse reactions occurring in ≥ 5 % of patients in the pilocarpine 2% populations were: headache/browache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain.

The adverse reaction profile reported for the use of Isopto® Carpine (pilocarpine) in pediatric patients is comparable to that seen in adult patients.

No information provided.

Last reviewed on RxList: 7/21/2010
This monograph has been modified to include the generic and brand name in many instances.