"For adults and children who undergo cataract surgery, implantation of an artificial lens is the standard of care. But a clinical trial suggests that for most infants, surgery followed by the use of contact lenses for several years â€” and an eventu"...
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of subjects as seen in the combined clinical trial results from three randomized, placebo-controlled studies.
Table 1: Ocular Adverse Reactions Reported by ≥
2% of Subjects
|MedDRA Preferred Term||Placebo
|Anterior Chamber Inflammation||102 (22%)||111 (24%)|
|Intraocular Pressure Increased||15 (3%)||20 (4%)|
|Posterior Capsule Opacification||16 (4%)||18 (4%)|
|Eye Irritation||6 (1%)||9 (2%)|
|Foreign Body Sensation in Eyes||11 (2%)||8 (2%)|
Read the Omidria (phenylephrine and ketorolac injection) Side Effects Center for a complete guide to possible side effects
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Last reviewed on RxList: 6/16/2014
This monograph has been modified to include the generic and brand name in many instances.
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