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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
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.
Details
| Lead sponsor | Alcon Research |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 64 |
| Start date | 2008-09 |
Conditions
- Cataract
Interventions
- Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Primary outcomes
- 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
Countries
United States