Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induct... | NCT00520260

Studies
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

NCT00520260

Sponsor

Florida Eye Microsurgical Institute

Status

Completed

Last Update Posted

Feb 19, 2009Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Dry Eye Disease
Ocular Comfort

Interventions

bromfenac
ketorolac

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 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

Aug 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Aug 21, 2007

First Submission Date that Met QC Criteria

Aug 22, 2007

First Posted Date

Aug 23, 2007Estimated

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

Feb 17, 2009

Last Update Posted Date

Feb 19, 2009Estimated

Name	Class
Bausch & Lomb Incorporated	INDUSTRY

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

To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease

Detailed Description

Not provided

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Active treatment arm bromfenac 0.09% BID for 6 weeks	Drug: bromfenac
2	Active Comparator	ketorolac 0.4% BID for 6 weeks	Drug: ketorolac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bromfenac	Drug	0.09%, BID, 6 weeks	1
ketorolac

Measure	Description	Time Frame
Ocular comfort		six weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be in general good health
Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
Patients who are pregnant or nursing females
Unwilling to discontinue use of contact lenses during the run-in and duration of the study
Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
Previous treatment failure on CSA 0.05% (Restasis)
Known hypersensitivity to any component of the study or procedural medications
Participation in any other clinical trial within 30 days prior to screening
Known contraindication to any study medication or any of their components.
Should not be taking any oral anti-histamines, beta blockers or diuretics.

Accepts Healthy Volunteers

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
Barry Schechter, MD	Florida Eye Microsurgical Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Eye Microsurgical Institute		Boynton Beach	Florida	33426	United States

Type	Date	Date Unknown
Release	Mar 14, 2012
Reset	Apr 9, 2012
Release	Apr 18, 2012
Reset	May 15, 2012

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C053083	bromfenac
D020910	Ketorolac

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 14, 2012			Apr 9, 2012
Apr 18, 2012