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Completed

NCT Number: NCT00781300

Intraocular Pressure With Loteprednol and Dexamethasone

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.

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Key information

Conditions

Glaucoma, Open-Angle Conjunctival Diseases Eye Diseases Glaucoma Ocular Hypertension Pterygium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Opthalmology, Federal University of São Paulo

São Paulo, 04023-062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loteprednol Etabonate 0.5%

Drug

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

Other names: Loteprol, Lotemax

Dexamethasone 0.1%

Drug

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 names: Tobradex

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: Once a week for the first 4 weeks and 6 weeks after the procedure

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

A Randomized Clinical Trial Comparing the Intraocular Pressure Changes With the Use of Loteprednol and Dexamethasone After Pterygium Surgery

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Oct 28, 2008
Registry last updated
Oct 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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