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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-

Brief Summary: 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.

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome:

• The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. [ Time Frame: Day 15 after cataract surgery ]

  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

• The Percentage of Patients With no Ocular Pain [ Time Frame: Day 15 after cataract surgery ]

Original Primary Outcome: Ocular pain evaluation;Slit lamp examination;IOP [ Time Frame: Day -2; Day 1; Day 3; Day 8; Day 15 ]

Current Secondary Outcome:

Original Secondary Outcome: Physician's Follow-up Impression of Inflammatory Reaction [ Time Frame: Day 1; Day 3; Day 8; Day 15 ]

Information By: Alcon Research

Dates:
Date Received: September 26, 2008
Date Started: September 2008
Date Completion:
Last Updated: March 3, 2010
Last Verified: March 2010