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Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Primary Purpose

Pain, Inflammation

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

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain and Inflammation as a function of cataract surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

  • Have known hypersensitivity to bromfenac or to any component of the investigational product

Sites / Locations

  • ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bromfenac ophthalmic solution 0.09%

Placebo

Arm Description

dosed 1 drop daily in study eye for 2 weeks

dosed 1 drop daily in study eye for 2 weeks

Outcomes

Primary Outcome Measures

Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 0. Measured on a scale of 0-4: 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

Pain Free
Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

Full Information

First Posted
February 26, 2009
Last Updated
January 11, 2013
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00853970
Brief Title
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 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

5. Study Description

Brief Summary
Efficacy study 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
Pain, Inflammation
Keywords
Pain and Inflammation as a function of cataract surgery

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bromfenac ophthalmic solution 0.09%
Arm Type
Experimental
Arm Description
dosed 1 drop daily in study eye for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
dosed 1 drop daily in study eye for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Bromfenac Ophthalmic Solution
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Summed Ocular Inflammation Score (SOIS) of Zero
Description
Participants with SOIS of 0. Measured on a scale of 0-4: 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 (Primary Endpoint)
Secondary Outcome Measure Information:
Title
Pain Free
Description
Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female at least 18 years of age who are scheduled for unilateral cataract surgery Exclusion Criteria: Have known hypersensitivity to bromfenac or to any component of the investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
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 Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

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