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Bromfenac Ophthalmic Solution in Dry Eye Disease
NCT01212471Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- Aug 2011
- Countries
- 1
- Sponsor
- Bausch + Lomb
- Modality
- Small Molecules
- Drugs
- bromfenac sodium
- Conditions
- dry eye disease (DED)
01
Overview
Phase 3, randomised, double-blind trial of bromfenac sodium in dry eye disease (DED) (3 arms), sponsored by Bausch + Lomb. Primary endpoint: Mean Ocular Surface Disease Index Total Score at 42 days. Started Sep 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Bromfenac A
Bromfenac Ophthalmic Solution A
Bromfenac B
Bromfenac Ophthalmic Solution B
Placebo
Placebo Comparator
03
Who it enrols
Adult patients 18 years or older with Dry Eye Syndrome, excluding those with local or systemic diseases that could interfere with the study.
04
Endpoints
Primary
Mean Ocular Surface Disease Index Total Score
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