NCT00781300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
Last Updated

October 28, 2008

Status Verified

October 1, 2008

Enrollment Period

8 months

First QC Date

October 27, 2008

Last Update Submit

October 27, 2008

Conditions

Glaucoma, Open-AngleOcular Hypertension

Keywords

Intraocular pressurePterygiumSurgerySteroidsGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    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

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

Study Arms (2)

Loteprednol

ACTIVE COMPARATOR
Drug: Loteprednol Etabonate 0.5%

Dexamethasone

ACTIVE COMPARATOR
Drug: Dexamethasone 0.1%

Interventions

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

Also known as: Loteprol, Lotemax
Loteprednol
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.

Also known as: Tobradex
Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: eighteen years old or more
  • IOP: less than 22mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Opthalmology, Federal University of São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionPterygiumGlaucoma

Interventions

Loteprednol EtabonateTobramycin, Dexamethasone Drug Combination

Condition Hierarchy (Ancestors)

Eye DiseasesConjunctival Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDexamethasonePregnadienetriolsPregnadienesPregnanesSteroids, FluorinatedTobramycinNebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Luciano M Pinto, MD

    Fedreal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

March 1, 2006

Primary Completion

November 1, 2006

Study Completion

February 1, 2007

Last Updated

October 28, 2008

Record last verified: 2008-10

Locations

BR(1)