Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

Alcon Research64 enrolled

Overview

To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye dropsDRUG

1 drop every 6 hours into the study eye

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≧18 years of age * able to sign an informed consent and complete all required visits * intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL) * Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg) Exclusion Criteria: * Uncontrolled glaucoma or IOP * use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye * use of steroid during the study or within 14 days prior to enrollment

Locations (1)

Alcon Call Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.

The percentage of patients with a score of zero for Anterior chamber cells. Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm). Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon

Time frame: Day 15 after cataract surgery

The Percentage of Patients With no Ocular Pain

Time frame: Day 15 after cataract surgery

Data from ClinicalTrials.gov

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