Trial | NCT00992355  Report issue

Title

Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea tobramycin ketorolac ...

  • Study Participants

    97
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.
Study Started
Jan 31
2009
Primary Completion
Mar 31
2009
Study Completion
Apr 30
2009
Last Update
Oct 09
2009
Estimate

Drug Tobramycin 0.3% - Dexamethasone 0.1%

Drug Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%

Tobramycin 0.3% - Dexamethasone 0.1% Active Comparator

Tobramycin-Dexamethasone plus Ketorolac tromethamine Active Comparator

Criteria 

Inclusion Criteria:

Phacoemulsification (due to cataract)
Uneventful phacoemulsification surgery

Exclusion Criteria:

Disruption of the anterior lens capsule
Age-related macular degeneration
Proliferative diabetic retinopathy
Glaucoma
No Results Posted