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Intraocular Pressure With Loteprednol and Dexamethasone

NCT ID: NCT00781300

Last Updated: 2008-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Keywords

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Intraocular pressure Pterygium Surgery Steroids Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Loteprednol

Group Type ACTIVE_COMPARATOR

Loteprednol Etabonate 0.5%

Intervention Type 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

Dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone 0.1%

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Loteprol Lotemax Tobradex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of São Paulo

Principal Investigators

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Luciano M Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

Fedreal University of São Paulo

Locations

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Department of Opthalmology, Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP 1104/03

Identifier Type: -

Identifier Source: org_study_id