Back to resultsA Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bromfenac Ophthalmic Solution A
Bromfenac Ophthalmic Solution B
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Sign and symptoms of dry eye disease
Eligibility Criteria
Inclusion Criteria:
- Be of either gender and any race 18 years or older
Exclusion Criteria:
- Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Bromfenac Ophthalmic Solution A
Bromfenac Ophthalmic Solution B
Placebo Comparator
Arm Description
Bromfenac ophthalmic solution A
Bromfenac ophthalmic solution B
Placebo Comparator
Outcomes
Primary Outcome Measures
Mean Ocular Surface Disease Index (OSDI) Total Score
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Secondary Outcome Measures
Full Information
NCT ID
NCT01212471
First Posted
September 28, 2010
Last Updated
September 2, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01212471
Brief Title
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (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
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Sign and symptoms of dry eye disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
840 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bromfenac Ophthalmic Solution A
Arm Type
Experimental
Arm Description
Bromfenac ophthalmic solution A
Arm Title
Bromfenac Ophthalmic Solution B
Arm Type
Experimental
Arm Description
Bromfenac ophthalmic solution B
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bromfenac Ophthalmic Solution A
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Bromfenac Ophthalmic Solution B
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Ocular Surface Disease Index (OSDI) Total Score
Description
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be of either gender and any race 18 years or older
Exclusion Criteria:
Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study
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
Learn more about this trial
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
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