VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Pharmaceutical Solutions; Polystyrene sulfonic acid

Criteria

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.