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

Cataract Clinical Trial

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-cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870103
• Other study ID #: RM-08-05
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: March 3, 2010
• Start date: September 2008

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
1 drop every 6 hours into the study eye

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 15 after cataract surgery	Yes
Primary	The Percentage of Patients With no Ocular Pain		Day 15 after cataract surgery	No