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Bromfenac A

Phase 3

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

Bromfenac A target and mechanism

Molecular targetPTGS2, PTGS1
Target classInhibitor
ModalitySmall molecule

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

Bromfenac A clinical trials

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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Competitive Landscape -Acute Respiratory Distress Syndrome 27 trials (matched to "Dry Eye Syndrome")

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Frequently asked questions about Bromfenac A

What is Bromfenac A used for?

Bromfenac A is an investigational small molecule being studied for the treatment of dry eye syndrome, also known as dry eye disease. It is being developed by Bausch + Lomb Corporation and is in Phase 3 clinical development. It has not been approved by the FDA for dry eye syndrome.

What does Bromfenac A target?

Bromfenac A targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It is classified as an inhibitor of these enzymes. This mechanism is being investigated in the context of dry eye syndrome, a condition involving ocular surface inflammation.

Who makes Bromfenac A?

Bromfenac A is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is responsible for the clinical development of this ophthalmic small molecule for dry eye syndrome.

What phase is Bromfenac A in?

Bromfenac A is in Phase 3 clinical development for dry eye syndrome. It is an investigational therapy and has not been approved by the FDA. The Phase 3 program includes one completed trial, and no active trials are currently listed.

What clinical trials is Bromfenac A in?

Bromfenac A has been evaluated in one Phase 3 clinical trial, NCT01212471, titled A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease. This completed trial enrolled 840 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Bromfenac A the same as Bromfenac Ophthalmic Solution A?

Yes, Bromfenac A is also known as Bromfenac Ophthalmic Solution A. Both names refer to the same investigational small molecule being developed by Bausch + Lomb Corporation for dry eye syndrome. The alternative name reflects its ophthalmic solution formulation.