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Brinzolamide 1% AZOPT

Phase 2

Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Dec 29, 2015

Brinzolamide 1% AZOPT target and mechanism

Molecular targetCA2
Target classInhibitor
ModalitySmall molecule

Also known as Brinzolamide 1% ophthalmic suspension AZOPT®

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment327

FDA Designations

No designations recorded

Brinzolamide 1% AZOPT clinical trials

Brinzolamide 1% AZOPT · 1 trial · 2 indications

Phase 2 1
NCT021400606-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular HypertensionGlaucoma
COMPLETED327 Analytics
PHASE2COMPLETED
6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean IOP at Week 6
Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TravA/BrinzEXPERIMENTALDose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
TravB/BrinzEXPERIMENTALDose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
TravC/BrinzEXPERIMENTALDose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
AZOPTACTIVE_COMPARATORBrinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
TRAV ZACTIVE_COMPARATORBrinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
TRAV Z + AZOPTACTIVE_COMPARATORBrinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks

Interventions

NameTypeDescription
Dose Level A / Brinzolamide 1% ophthalmic suspensionDRUGFixed combination
Dose Level B / Brinzolamide 1% ophthalmic suspensionDRUGFixed combination
Dose Level C / Brinzolamide 1% ophthalmic suspensionDRUGFixed combination
Brinzolamide 1% ophthalmic suspension AZOPT®DRUG -
Travoprost 0.004% ophthalmic solution TRAVATAN Z®DRUG -
Travoprost solution vehicleDRUGInactive ingredients used for masking purposes
Brinzolamide suspension vehicleDRUGInactive ingredients used for masking purposes
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; * IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be \>36 mmHg at any time point; * Able to...

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Frequently asked questions about Brinzolamide 1% AZOPT

What is Brinzolamide 1% AZOPT used for?

Brinzolamide 1% AZOPT is an ophthalmic suspension being studied for glaucoma and ocular hypertension. It is a small molecule carbonic anhydrase inhibitor developed by Alcon Inc. (ticker ALC). The drug is in Phase 2 clinical development, with one completed trial in patients with open-angle glaucoma or ocular hypertension.

What does Brinzolamide 1% AZOPT target?

Brinzolamide 1% AZOPT targets carbonic anhydrase 2 (CA2). It is a CA2 inhibitor. By inhibiting this enzyme in the ciliary body, the drug reduces aqueous humor production, which can lower intraocular pressure in conditions such as glaucoma and ocular hypertension.

Who makes Brinzolamide 1% AZOPT?

Brinzolamide 1% AZOPT is developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company focused on ophthalmic pharmaceuticals and devices. The drug is part of its glaucoma portfolio.

What phase is Brinzolamide 1% AZOPT in?

Brinzolamide 1% AZOPT is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for the studied indications. One Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is Brinzolamide 1% AZOPT in?

Brinzolamide 1% AZOPT has been evaluated in a completed Phase 2 trial, NCT02140060, titled "6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension." The randomized, double-blind, active-controlled study enrolled 327 participants aged 18 years and older.

Is Brinzolamide 1% AZOPT the same as Brinzolamide 1% ophthalmic suspension AZOPT?

Yes, Brinzolamide 1% AZOPT is also known as Brinzolamide 1% ophthalmic suspension AZOPT. Both names refer to the same product developed by Alcon Inc. for glaucoma and ocular hypertension.