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

Completed · Phase 4

Conditions studied: Cataract Extraction

In brief

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.

Key facts

Study ID

NCT00366691

Run by

Medical University of South Carolina

People needed

40

Starts

2006-02-01

Expected to finish

2007-09-01

Last updated by the study team

2018-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Storm Eye Institute, Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.