Efficacy/Safety of Antibiotic Steroid Combination in Prev... | NCT00330824

Studies
Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

NCT00330824

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Aug 7, 2009Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Post Lasik Surgery Inflammation

Interventions

antibiotic/steroid combination
moxifloxacin/dexamethasone

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

Aug 2009

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

Apr 2006

Primary Completion Date

Sep 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

May 26, 2006

First Submission Date that Met QC Criteria

May 26, 2006

First Posted Date

May 29, 2006Estimated

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

Aug 6, 2009

Last Update Posted Date

Aug 7, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

Detailed Description

antibiotic/steroid combination compared to individuals components 15 days of treatment

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
antibiotic steroid (single vial)	Experimental	efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery	Drug: antibiotic/steroid combination
antibiotic / steroid (2 vials)	Active Comparator	efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having LASIK surgery	Drug: moxifloxacin/dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antibiotic/steroid combination	Drug	1gtt, 4x/d, 15 days	antibiotic steroid (single vial)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
day 15 evaluation of anterior chamber		15 days pos-op

Secondary Outcomes

Measure	Description	Time Frame
day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score		15 days pos-op

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients having LASIK surgery;
men or women of any race, between 18 and 50 years old, presenting up to 8 degrees of myopia or up to 4 degrees of hypermetropia, or up to 3 degrees of astigmatism, without any other associated ocular problems

Exclusion Criteria:

Uncontrolled glaucoma or intraocular hypertension;
Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
A history of chronic or recurrent ocular inflammatory disease;
Uncontrolled diabetes mellitus and diabetic retinopathy ;
Patients with sight in a single eye;
Iris atrophy in the eye to be operated;
Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
Known or suspected allergy or hypersensitivity to any component of study medication;
A history or any other evidence of severe systemic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rubens Belfort Jr, MD, PhD	Federal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Ophthalmology - Rua Botucatu 824		São Paulo	São Paulo	04023-062	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D000900	Anti-Bacterial Agents
D000077266	Moxifloxacin
D003907	Dexamethasone

Ancestor Terms

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

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Browse Branches

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