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Brinzolamide 1% AZOPT

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment327

FDA Designations

No designations recorded

Clinical trial landscape

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 used for glaucoma, specifically in the treatment of open-angle glaucoma or ocular hypertension. It is an ophthalmic suspension being studied as a combination therapy with travoprost. The drug is administered to lower intraocular pressure in patients with these conditions.

Who makes Brinzolamide 1% AZOPT?

Brinzolamide 1% AZOPT is developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. Alcon is the developer of this investigational ophthalmic product, which is currently in clinical development for the treatment of glaucoma.

What phase is Brinzolamide 1% AZOPT in?

Brinzolamide 1% AZOPT is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for the treatment of glaucoma and ocular hypertension.

What clinical trials is Brinzolamide 1% AZOPT in?

Brinzolamide 1% AZOPT is associated with one completed clinical trial, NCT02140060, a Phase 2 proof-of-concept study. This 6-week study evaluated travoprost/brinzolamide ophthalmic suspension in 327 participants with open-angle glaucoma or ocular hypertension. The trial was randomized, double-blind, and active-controlled.

Is Brinzolamide 1% AZOPT the same as travoprost/brinzolamide?

Brinzolamide 1% AZOPT is a component of the combination product travoprost/brinzolamide ophthalmic suspension. The clinical trial NCT02140060 studied this combination, which includes brinzolamide 1% (AZOPT) along with travoprost. The study was designed to evaluate the efficacy of this fixed-dose combination in lowering intraocular pressure.