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Bromfenac A

Phase 3

Dry Eye Syndrome | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Sep 4, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment840

FDA Designations

No designations recorded

Clinical trial landscape

Bromfenac A · 1 trial · 1 indication

Phase 3 1
NCT01212471A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye DiseaseDry Eye Syndrome
COMPLETED840 Analytics
PHASE3COMPLETED
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Dry Eye SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Ocular Surface Disease Index (OSDI) Total Score
42 days

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bromfenac Ophthalmic Solution AEXPERIMENTALBromfenac ophthalmic solution A
Bromfenac Ophthalmic Solution BEXPERIMENTALBromfenac ophthalmic solution B
Placebo ComparatorPLACEBO_COMPARATORPlacebo Comparator

Interventions

NameTypeDescription
Bromfenac Ophthalmic Solution ADRUGsterile ophthalmic solution
Bromfenac Ophthalmic Solution BDRUGsterile ophthalmic solution
Placebo ComparatorDRUGsterile ophthalmic solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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

Countries:United States
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Frequently asked questions about Bromfenac A

What is Bromfenac A used for?

Bromfenac A is an investigational small molecule being developed for the treatment of Dry Eye Syndrome. It is formulated as an ophthalmic solution and is currently in Phase 3 clinical development. The drug is being studied for its safety and efficacy in patients with this condition.

Who makes Bromfenac A?

Bromfenac A is being developed by Bausch + Lomb Corporation, a company traded on the stock exchange under the ticker symbol BLCO. The company is conducting clinical research on this ophthalmic solution for Dry Eye Syndrome.

What phase is Bromfenac A in?

Bromfenac A is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its safety and efficacy in patients with Dry Eye Syndrome.

What clinical trials is Bromfenac A in?

Bromfenac A has one completed Phase 3 clinical trial registered as NCT01212471. This was a dose-ranging study that evaluated the safety and efficacy of Bromfenac ophthalmic solution in Dry Eye Disease. The trial enrolled 840 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Bromfenac A the same as Bromfenac?

Bromfenac A is a specific formulation of bromfenac, a nonsteroidal anti-inflammatory drug, developed as an ophthalmic solution for Dry Eye Syndrome. While the active ingredient is bromfenac, Bromfenac A refers to this particular investigational product being studied by Bausch + Lomb.