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: Loteprednol Etabonate; Drug: Vehicle of Loteprednol Etabonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010633

576

Details and patient eligibility

About

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.

Enrollment: 406 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.
• Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

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 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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406 participants in 2 patient groups, including a placebo group

Loteprednol Etabonate

Experimental group

Description:

Loteprednol etabonate

Treatment:

Drug: Loteprednol Etabonate

Vehicle

Placebo Comparator group

Description:

Vehicle of loteprednol etabonate

Treatment:

Drug: Vehicle of Loteprednol Etabonate