drugset / Trial / NCT00992355

Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery

NCT00992355

Completed 97 enrolled Veroia General Hospital
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

EvaluationDrugModalityDoseRoute
Comparator Ketorolac Other / unclassified 0.5 % Topical
Comparator Dexamethasone Small molecule 0.1 % Topical
Comparator Tobramycin Small molecule 0.3 % Topical

Indications