Intraocular Pressure With Loteprednol and Dexamethasone

This study has been completed.

Sponsor:

Information provided by:

Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT00781300

First received: October 27, 2008

Last updated: NA

Last verified: October 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 27, 2008

Last Updated Date

October 27, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular Pressure (IOP) [ Time Frame: Once a week for the first 4 weeks and 6 weeks after the procedure ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intraocular Pressure With Loteprednol and Dexamethasone

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma, Open-Angle
Ocular Hypertension

Intervention ^ICMJE

Drug: 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
Other Names:
- Loteprol
- Lotemax
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.

Other Name: Tobradex

Study Arm (s)

Active Comparator: Loteprednol
Intervention: Drug: Loteprednol Etabonate 0.5%
Active Comparator: Dexamethasone
Intervention: Drug: Dexamethasone 0.1%

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00781300

Other Study ID Numbers ^ICMJE

CEP 1104/03

Has Data Monitoring Committee

Responsible Party

Luciano Moreira Pinto, MD, Federal University of São Paulo

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Luciano M Pinto, MD

Fedreal University of São Paulo

Information Provided By

Federal University of São Paulo

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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