Back to resultsStudy of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract
Eligibility Criteria
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
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vigadexa eye drops
Arm Description
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Outcomes
Primary Outcome Measures
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
The Percentage of Patients With no Ocular Pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00870103
Brief Title
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vigadexa eye drops
Arm Type
Experimental
Arm Description
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Intervention Type
Drug
Intervention Name(s)
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Intervention Description
1 drop every 6 hours into the study eye
Primary Outcome Measure Information:
Title
The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.
Description
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
Title
The Percentage of Patients With no Ocular Pain
Time Frame
Day 15 after cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
We'll reach out to this number within 24 hrs