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NCT01212471 Clinical Trial

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01212471
Other study ID # S00007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2010
Est. completion date December 2011

Study information
Verified date September 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Recruitment information / eligibility
Status Completed
Enrollment 840
Est. completion date December 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bromfenac Ophthalmic Solution A
sterile ophthalmic solution
• Bromfenac Ophthalmic Solution B
sterile ophthalmic solution
• Placebo Comparator
sterile ophthalmic solution

Locations
Country Name City State
United States ISTA Pharmaceuticals, Inc. Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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