Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

Completed · Phase 3

Conditions studied: Ocular Inflammation

In brief

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Key facts

Study ID

NCT00645671

Run by

Bausch & Lomb Incorporated

People needed

400

Starts

2008-03-01

Expected to finish

2009-03-01

Last updated by the study team

2015-03-24

Who can join

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

You may qualify if…

• Subjects who are candidate 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 will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
• Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
• Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Where it is running

• John Hunkeler, MD — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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