Intraocular Pressure With Loteprednol and Dexamethasone | NCT00781300

Studies
Intraocular Pressure With Loteprednol and Dexamethasone

NCT00781300

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Oct 28, 2008Estimated

Enrollment

35Actual

Phase

Phase 4

Conditions

Glaucoma, Open-Angle
Ocular Hypertension

Interventions

Loteprednol Etabonate 0.5%
Dexamethasone 0.1%

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Feb 2007Actual

First Submitted Date

Oct 27, 2008

First Submission Date that Met QC Criteria

Oct 27, 2008

First Posted Date

Oct 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2008

Last Update Posted Date

Oct 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Loteprednol	Active Comparator		Drug: Loteprednol Etabonate 0.5%
Dexamethasone	Active Comparator		Drug: Dexamethasone 0.1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular Pressure (IOP)		Once a week for the first 4 weeks and 6 weeks after the procedure

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luciano M Pinto, MD	Fedreal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Opthalmology, Federal University of São Paulo		São Paulo	São Paulo	04023-062	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension
D011625	Pterygium
D005901	Glaucoma

Ancestor Terms

ID	Term
D005128	Eye Diseases
D003229	Conjunctival Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069559	Loteprednol Etabonate
D000078162	Tobramycin, Dexamethasone Drug Combination

Ancestor Terms

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided