Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch & Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Ketorolac; Ketorolac Tromethamine; Loteprednol Etabonate

Criteria

Inclusion Criteria:

• Subject must have a visually significant age-related cataract, in the planned operated eye.

• 18 years of age or older.

• The vision in the fellow, unoperated eye should have a potential visual acuity of 20/40 or better as determined by the principal investigator.

• Patient must desire cataract extraction.

• Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

• Advanced glaucomatous damage.

• Any abnormality preventing reliable applanation tonometry in operated eye.

• Contact lens use during the active treatment portion of the trial in the operated eye.

• Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye.

• Any history of allergic hypersensitivity or poor tolerance to any component of the preparations used in this trial.

• Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.

• Any clinically significant, serious or severe medical or psychiatric condition.

• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.

• Required use of other topical medications during the active portion of the trial except prophylactic antibiotic, topical lid care, tear replacement solutions or glaucoma medications.

• Other ocular surgery at the time of the cataract extraction.

• Use of topical or oral antiprostaglandins or corticosteroids as well as aspirin products (> 81 mg) during the active treatment portion of the trial. If patient wants to participate in the trial and can stop the medication, he/she can be enrolled after 7-day wash out period.