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Travoprost, 0.00013%

Phase 3

Open-angle Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: May 5, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment1,549

FDA Designations

No designations recorded

Clinical trial landscape

Travoprost, 0.00013% · 5 trials · 2 indications

Phase 3 2Phase 2 3
NCT01453855Travoprost 3-Month Safety and Efficacy StudyOpen-Angle Glaucoma
COMPLETED1,099 Analytics
NCT00293761A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular HypertensionOpen-angle Glaucoma
COMPLETED109 Analytics
PHASE3COMPLETED
Travoprost 3-Month Safety and Efficacy Study
Open-Angle GlaucomaUnlock trial analytics
PHASE3COMPLETED
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Open-angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)

As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Mean IOP
24-hour Area Under the Curve (AUC) in IOP Reduction
Day 5
Mean Intraocular Pressure
Up to 2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Travoprost 0.003%EXPERIMENTALTravoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
TRAVATANACTIVE_COMPARATORTravoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Travatan, InvestigationalEXPERIMENTAL -
Trav 0.00013%EXPERIMENTALTravoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Trav 0.00033%EXPERIMENTALTravoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Trav 0.001%EXPERIMENTALTravoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Trav 0.00267%EXPERIMENTALTravoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
VehiclePLACEBO_COMPARATORTravoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
Travoprost 0.0008%EXPERIMENTALTravoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Travoprost 0.001%EXPERIMENTALTravoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
Travoprost 0.0012%EXPERIMENTALTravoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks
TRAVATAN + VehicleACTIVE_COMPARATORTRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks

Interventions

NameTypeDescription
Travoprost ophthalmic solution, 0.003%DRUG -
Travoprost ophthalmic solution, 0.004%DRUG -
Travoprost, InvestigationalDRUGOne drop in study eye once daily for 13 days
Travoprost (TRAVATAN)DRUGOne drop in study eye once daily for 13 days
Travoprost Ophthalmic Solution, 0.00013%DRUGCumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.00033%DRUGCumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.001%DRUGCumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.00267%DRUGCumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost VehicleDRUGInactive ingredients used as an active comparator
Travoprost ophthalmic solution, 0.0008%DRUG -
Travoprost ophthalmic solution, 0.0012%DRUG -
TRAVATANDRUG -
VehicleOTHER -
Travoprost/brinzolamideDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension. * Qualifying intraocular pressure at both eligibility visits. * Understand and sign an informed consent form. * Other protocol-defined inclusio...

Countries:United States
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Competitive Landscape -Open-Angle Glaucoma 9 trials

Frequently asked questions about Travoprost, 0.00013%

What is Travoprost used for?

Travoprost is used for lowering intraocular pressure in patients with ocular hypertension and glaucoma, including open-angle glaucoma and angle-closure glaucoma. It is a small molecule developed by Alcon Inc. for the ophthalmology therapeutic area and is currently in Phase 3 clinical development.

What does Travoprost target?

Travoprost is a prostaglandin analog that works by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure. It is being studied for its efficacy in treating open-angle glaucoma and ocular hypertension, with clinical trials comparing it to other prostaglandin analogs.

Who makes Travoprost?

Travoprost is developed by Alcon Inc., a company traded under the ticker symbol ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of Travoprost in patients with glaucoma and ocular hypertension.

What phase is Travoprost in?

Travoprost is in Phase 3 clinical development. It has completed five clinical trials, including Phase 3 studies, with a total enrollment of 1,549 participants. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is Travoprost in?

Travoprost has been studied in several clinical trials, including NCT00051142 and NCT00051155, which are Phase 3 trials comparing Travoprost to other glaucoma medications. Additional Phase 2 trials, such as NCT00637130 and NCT01298687, have also been completed to evaluate its safety and efficacy.

Is Travoprost the same as Travatan?

Travoprost is also known by the brand name Travatan. Clinical trials, such as NCT01298687, refer to the drug as TRAVATAN, confirming that Travoprost and Travatan are the same medication.