Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Completed · Phase 3

Conditions studied: Inflammation, Pain

In brief

This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Key facts

Study ID

NCT01010633

Run by

Bausch & Lomb Incorporated

People needed

406

Starts

2009-11-01

Expected to finish

2010-08-01

Last updated by the study team

2012-01-09

Who can join

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

You may qualify if…

• Subjects who are at least 18 years of age.
• Subjects who are candidates for routine, uncomplicated cataract surgery.
• Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

You may not qualify if…

• Subjects who have known hypersensitivity or contraindication to the study drug or components.
• Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
• Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.

Where it is running

• Bausch & Lomb, Inc. — Rochester, New York, United States

Full record on ClinicalTrials.gov

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