Intraocular Pressure With Loteprednol and Dexamethasone
|Glaucoma, Open-Angle Ocular Hypertension||Drug: Loteprednol Etabonate 0.5% Drug: Dexamethasone 0.1%||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery|
- Intraocular Pressure (IOP) [ Time Frame: Once a week for the first 4 weeks and 6 weeks after the procedure ]
- IOP difference between the operated eye and the fellow eye [ Time Frame: Once a week for the first 4 weeks and then 6 weeks after the procedure ]
|Study Start Date:||March 2006|
|Study Completion Date:||February 2007|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: Loteprednol||
Drug: Loteprednol Etabonate 0.5%
Patients in the Loteprednol Group received Loteprednol Etabonate 0.5% associated with Tobramycin 0.3% in separate eyedrops for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week
|Active Comparator: Dexamethasone||
Drug: Dexamethasone 0.1%
The patients in Dexamethasone Group received Dexamethasone 0.1% associated with Tobramycin 0.3% in a single eyedrop for four weeks: 6 times a day during the first postoperative week, 4 times a day during the second week, 3 times a day during the third week and twice-daily during the fourth week.
Other Name: Tobradex
Surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. Corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. However, use of topical corticosteroids can induce an elevation in intraocular pressure (IOP) due to a reduction in the facility of aqueous outflow.
Loteprednol etabonate (LE) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing IOP elevation. LE showed less effect on IOP than Prednisolone Acetate. This probably occurs due to lower levels of LE in the aqueous humor.
Some trials compare LE to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. To our knowledge, there are no trials studying the effect of LE on IOP after pterygium surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781300
|Department of Opthalmology, Federal University of São Paulo|
|São Paulo, SP, Brazil, 04023-062|
|Principal Investigator:||Luciano M Pinto, MD||Fedreal University of São Paulo|