Voltaren Ophthalmic (Diclofenac Sodium Ophthalmic Solution) Drug Information: Clinical Pharmacology

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May 27, 2012

Voltaren Ophthalmic

Cataracts »

Facts about cataracts

A cataract is a clouding of the lens of the eye.
Cataracts are extremely common, and most cataracts are a result of the aging process.
Although many cataracts are not significant enough to require treatment, surgical removal of cataracts is usually safe and effective, resulting in improvement of vision.
Cataract surgery should be performed when the visual loss from the cataract significantly impacts the lifestyle of the individual patient.

What is a cataract?

A cataract is an eye disease in which the clear lens of the eye becomes cloudy opaque, causing decrease in vision. Although the word cataract to describe this condition has been part of the English language only since the middle of the 16th century, the eye disease has been recognized and surgically treated since ancient times.

The lens is a portion of ...

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Voltaren Ophthalmic

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CLINICAL PHARMACOLOGY

Pharmacodynamics

Diclofenac sodium is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. It is thought to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of prostaglandins.

Animal Studies

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Pharmacokinetics

Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of Voltaren Ophthalmic to each eye were below the limit of quantification (10 ng/mL) over a 4-hour period. This study suggests that limited, if any, systemic absorption occurs with Voltaren Ophthalmic.

Clinical Trials

Postoperative Anti-Inflammatory Effects

In two double-masked, controlled, efficacy studies of postoperative inflammation, a total of 206 cataract patients were treated with Voltaren Ophthalmic and 103 patients were treated with vehicle placebo. Voltaren Ophthalmic was favored over vehicle placebo over a 2-week period for the clinical assessments of inflammation as measured by anterior chamber cells and flare.

In double-masked, controlled studies of corneal refractive surgery (radial keratotomy (RK) and laser photorefractive keratectomy (PRK)) patients were treated with Voltaren Ophthalmic and/or vehicle placebo. The efficacy of Voltaren Ophthalmic given before and shortly after surgery was favored over vehicle placebo during the 6-hour period following surgery for the clinical assessments of pain and photophobia. Patients were permitted to use a hydrogel soft contact lens with Voltaren Ophthalmic for up to three days after PRK.

Last reviewed on RxList: 6/2/2011
This monograph has been modified to include the generic and brand name in many instances.