Intraocular Pressure With Loteprednol and Dexamethasone

Phase 4

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: Loteprednol Etabonate 0.5%; Drug: Dexamethasone 0.1%

• Registration Number: NCT00781300
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-11
• Study Completion: 2007-02
• Status Verified: 2008-10
• Study First Submitted: 2008-10-27
• Study First Submitted QC: 2008-10-27
• Last Update Submitted: 2008-10-27
• Study First Posted: 2008-10-28
• Last Update Posted: 2008-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Age: eighteen years old or more
• IOP: less than 22mmHg

Exclusion Criteria

• History of previous ocular surgery
• Use of topical or systemic corticosteroids for up to a month before the surgery
• Extensive pterygia that disabled accurate IOP measurement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol	Loteprednol Etabonate 0.5%	-
Dexamethasone	Dexamethasone 0.1%	-

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	Once a week for the first 4 weeks and 6 weeks after the procedure

Secondary Outcome Measures

Name	Time	Method
IOP difference between the operated eye and the fellow eye	Once a week for the first 4 weeks and then 6 weeks after the procedure

Trial Locations

Locations (1)

Department of Opthalmology, Federal University of São Paulo; 🇧🇷 São Paulo, SP, Brazil