A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
1 other identifier
interventional
840
1 country
1
Brief Summary
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
September 4, 2020
CompletedSeptember 4, 2020
September 1, 2020
11 months
September 28, 2010
August 18, 2020
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
42 days
Study Arms (3)
Bromfenac Ophthalmic Solution A
EXPERIMENTALBromfenac ophthalmic solution A
Bromfenac Ophthalmic Solution B
EXPERIMENTALBromfenac ophthalmic solution B
Placebo Comparator
PLACEBO COMPARATORPlacebo Comparator
Interventions
Eligibility Criteria
You may qualify if:
- Be of either gender and any race 18 years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Tim McNamara, PharmD
ISTA Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2010
First Posted
September 30, 2010
Study Start
September 1, 2010
Primary Completion
August 1, 2011
Study Completion
December 1, 2011
Last Updated
September 4, 2020
Results First Posted
September 4, 2020
Record last verified: 2020-09