Back to results

Intraocular Pressure With Loteprednol and Dexamethasone

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Loteprednol Etabonate 0.5%

Dexamethasone 0.1%

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Intraocular pressure, Pterygium, Surgery, Steroids, Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Department of Opthalmology, Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Loteprednol

Dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)

Secondary Outcome Measures

IOP difference between the operated eye and the fellow eye

Full Information

NCT ID

NCT00781300

First Posted

October 27, 2008

Last Updated

October 27, 2008

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00781300

Brief Title

Intraocular Pressure With Loteprednol and Dexamethasone

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle, Ocular Hypertension

Keywords

Intraocular pressure, Pterygium, Surgery, Steroids, Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loteprednol

Arm Type

Active Comparator

Arm Title

Dexamethasone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Loteprednol Etabonate 0.5%

Other Intervention Name(s)

Loteprol, Lotemax

Intervention Description

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

Intervention Name(s)

Dexamethasone 0.1%

Other Intervention Name(s)

Tobradex

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intraocular Pressure (IOP)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luciano M Pinto, MD

Organizational Affiliation

Fedreal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Opthalmology, Federal University of São Paulo

City

São Paulo

State/Province

ZIP/Postal Code

04023-062

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Intraocular Pressure With Loteprednol and Dexamethasone

We'll reach out to this number within 24 hrs