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

Primary Purpose

Pain, Inflammation

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

bromfenac ophthalmic solution

placebo comparator

About this trial

This is an interventional treatment trial for Pain focused on measuring Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1-bromfenac ophthalmic solution

2-placebo comparator

Arm Description

sterile ophthalmic solution

Outcomes

Primary Outcome Measures

Reduction of ocular inflammation

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00333918

First Posted

June 4, 2006

Last Updated

February 13, 2013

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00333918

Brief Title

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

Official Title

Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Inflammation

Keywords

Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

522 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1-bromfenac ophthalmic solution

Arm Type

Experimental

Arm Description

sterile ophthalmic solution

Arm Title

2-placebo comparator

Arm Type

Placebo Comparator

Arm Description

sterile ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

bromfenac ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

placebo comparator

Primary Outcome Measure Information:

Title

Reduction of ocular inflammation

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Bianca, PhD

Organizational Affiliation

ISTA Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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