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

Phase 4

Completed

• Conditions: Cataract
• Interventions: Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

• Registration Number: NCT00870103
• Lead Sponsor: Alcon Research

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 Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-26
• Primary Completion: 2009-02
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Results First Submitted: 2010-01-14
• Results First Submitted QC: 2010-01-21
• Results First Posted: 2010-02-15
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-03
• Last Update Posted: 2010-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vigadexa eye drops	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops	Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.	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	Day 15 after cataract surgery

Trial Locations

Locations (1)

Alcon Call Center; 🇺🇸 Fort Worth, Texas, United States