Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocul... | NCT00333918

Studies
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

NCT00333918

Sponsor

Bausch & Lomb Incorporated

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

522Actual

Phase

Phase 3

Conditions

Pain
Inflammation

Interventions

bromfenac ophthalmic solution
placebo comparator

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

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

Feb 2013

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

Jun 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Jun 4, 2006

First Submission Date that Met QC Criteria

Jun 5, 2006

First Posted Date

Jun 6, 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

Feb 13, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Description Module

Brief Summary

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

522Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1-bromfenac ophthalmic solution	Experimental	sterile ophthalmic solution	Drug: bromfenac ophthalmic solution
2-placebo comparator	Placebo Comparator	sterile ophthalmic solution	Drug: placebo comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bromfenac ophthalmic solution	Drug		1-bromfenac ophthalmic solution
placebo comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of ocular inflammation

Secondary Outcomes

Measure	Description	Time Frame
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
Agree to return for all required visits
Agree to avoid disallowed medications

Exclusion Criteria:

Known hypersensitivity to bromfenac and salicylates

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
Ralph Bianca, PhD	ISTA Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Irvine	California	92618	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D007249	Inflammation

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided