VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

• Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.
• Percentage of patients with no clinically evidenced bacterial infection [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.

• Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.
• Percentage of patients with no clinically evidenced bacterial infection [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.

• Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.
• Ocular pain (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during patient interview.
• Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.

• Cells in the anterior chamber (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.
• Ocular pain (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during patient interview.
• Inflammatory reaction (study eye) [ Time Frame: Day 15 post-operative or upon study exit, if earlier ] [ Designated as safety issue: Yes ]
  As assessed by the investigator during slit-lamp examination.

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.

• Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
  One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
  Other Name: FID 119149, VIGADEXA Gel
• Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
  One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
  Other Name: VIGADEXA Solution

• Experimental: VIGADEXA Gel
  VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
  Intervention: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
• Active Comparator: VIGADEXA Solution
  VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
  Intervention: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)

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.