VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

Alcon Research

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Cataracts

Interventions

Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)DRUG

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.

Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.