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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bromfenac
Placebo
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract extraction, intraocular lens implantation

Eligibility Criteria

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

Inclusion Criteria:

  • Scheduled for cataract surgery

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates

Sites / Locations

  • ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bromfenac

Placebo

Arm Description

Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily

Placebo, dosed 1 drop daily

Outcomes

Primary Outcome Measures

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)

Secondary Outcome Measures

Number of Participants That Are Pain Free
Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses

Full Information

First Posted
June 20, 2008
Last Updated
January 11, 2013
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00704418
Brief Title
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract extraction, intraocular lens implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bromfenac
Arm Type
Experimental
Arm Description
Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, dosed 1 drop daily
Intervention Type
Drug
Intervention Name(s)
Bromfenac
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Description
Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of Participants That Are Pain Free
Description
Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for cataract surgery Exclusion Criteria: Known hypersensitivity to bromfenac and salicylates
Facility Information:
Facility Name
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21751945
Citation
Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
Results Reference
derived

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Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

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