Intraocular Pressure With Loteprednol and Dexamethasone

Federal University of São Paulo

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: Loteprednol Etabonate 0.5%; Drug: Dexamethasone 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT00781300

CEP 1104/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Loteprednol

Active Comparator group

Treatment:

Drug: Loteprednol Etabonate 0.5%

Dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone 0.1%