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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Inflammation; Pain

Treatments: Drug: Vehicle of Loteprednol Etabonate; Drug: Loteprednol etabonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01060072

577

Details and patient eligibility

About

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

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are at least 18 years of age.
• Subjects who are candidates for routine, uncomplicated cataract surgery.

Exclusion criteria

• 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 visual acuity (VA) 20/200 or worse in the non-study eye.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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407 participants in 2 patient groups, including a placebo group

Loteprednol etabonate

Experimental group

Description:

Loteprednol etabonate 0.5% ophthalmic suspension

Treatment:

Drug: Loteprednol etabonate

Vehicle

Placebo Comparator group

Description:

Vehicle of loteprednol etabonate ophthalmic suspension

Treatment:

Drug: Vehicle of Loteprednol Etabonate