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Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
Details
| Lead sponsor | Alcon Research |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2014-03 |
| Completion | 2014-10 |
Conditions
- Cataracts
Interventions
- Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
- Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
Primary outcomes
- Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber — Day 15 post-operative
As assessed by the investigator during slit-lamp examination. - Percentage of patients with no clinically evidenced bacterial infection — Day 15 post-operative
As assessed by the investigator during slit-lamp examination.