VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery

The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.

Inclusion Criteria:

• 18 years of age or older.
• Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
• Able to understand and sign an informed consent form.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Glaucoma or ocular hypertension.
• Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
• Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
• Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
• Planned use of contact lenses in the study eye during the study period.
• Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.
• History of clinically significant trauma to the study eye within the past 12 months.
• Other protocol-defined exclusion criteria may apply.