drugset / Trial / NCT00992355
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized controlled trial compares two regimens of topical therapy: * tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day * combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification. Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for * corneal edema * conjunctival redness * anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-03
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketorolac | Other / unclassified | 0.5 % | Topical |
| Comparator | Dexamethasone | Small molecule | 0.1 % | Topical |
| Comparator | Tobramycin | Small molecule | 0.3 % | Topical |