Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedResults Posted
Study results publicly available
February 15, 2010
CompletedMarch 9, 2010
March 1, 2010
5 months
September 26, 2008
January 14, 2010
March 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
The Percentage of Patients With no Ocular Pain
Day 15 after cataract surgery
Study Arms (1)
Vigadexa eye drops
EXPERIMENTALVigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Interventions
1 drop every 6 hours into the study eye
Eligibility Criteria
You may qualify if:
- ≧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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Call Center
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2008
First Posted
March 26, 2009
Study Start
September 1, 2008
Primary Completion
February 1, 2009
Last Updated
March 9, 2010
Results First Posted
February 15, 2010
Record last verified: 2010-03