A Phase 4 interventional study of Loteprednol Etabonate 0.5% and Dexamethasone 0.1% in Glaucoma, Open-Angle and Ocular Hypertension, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-28.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
The purpose of this study is to compare intraocular pressure (IOP) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 35 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Drug: Loteprednol Etabonate 0.5%
Drug: Dexamethasone 0.1%
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
Also known as: Loteprol, Lotemax
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.
Also known as: Tobradex
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
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo