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TRAVATAN

Phase 4FDA approved 2001

Glaucoma, Open-angle | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Oct 7, 2011

TRAVATAN development status

FDA approval Mar 16, 2001
Approval holderAlcon Pharms Ltd
ApplicationNDA021257
Highest phase Phase 4 (NCT00444665)
Phase scored for ALCPhase 3
Registered trials 16 across 3 sponsors since Jan 2003

TRAVATAN target and mechanism

ModalitySmall molecule

Also known as Travoprost 0.004% ophthalmic solution, TRAVATAN Z, Travoprost (TRAVATAN), Travoprost 0.004% ophthalmic solution (TRAVATAN)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment502

FDA Designations

No designations recorded

TRAVATAN clinical trials

TRAVATAN · 1 trial · 2 indications

Phase 3 1
NCT00051168A Long-term Safety Study of Once-daily TravatanGlaucoma, Open-angle
COMPLETED502 Analytics
PHASE3COMPLETED
A Long-term Safety Study of Once-daily Travatan
Glaucoma, Open-angleUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Intraocular Pressure
At 5 years.

Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken. All IOP measurements were performed with a Goldmann applanation tonometer.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TravatanEXPERIMENTALTravoprost (0.004%)

Interventions

NameTypeDescription
TravatanDRUGTravoprost (0.004%) 1 drop each eye once daily
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Eligibility Criteria

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

Adult patients of any race and either sex with chronic angle-closure glaucoma.

Countries:United States
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Frequently asked questions about TRAVATAN

What is TRAVATAN used for?

TRAVATAN is used to treat open-angle glaucoma and ocular hypertension. It is an ophthalmology medicine developed by Alcon Inc. and is given once daily. Its clinical development has focused on lowering pressure in the eye in adults aged 18 years and older.

Who makes TRAVATAN?

TRAVATAN is made by Alcon Inc., which trades under the ticker ALC. Alcon is the developer associated with the drug's clinical program in ophthalmology, including the long-term safety study conducted in the United States.

What phase is TRAVATAN in?

TRAVATAN has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was a long-term safety study of once-daily TRAVATAN conducted in the United States.

What clinical trials is TRAVATAN in?

TRAVATAN has been evaluated in the Phase 3 trial NCT00051168, titled A Long-term Safety Study of Once-daily Travatan. That trial enrolled 502 participants with open-angle glaucoma or ocular hypertension, was conducted in the United States, and has been completed.

How many patients were enrolled in TRAVATAN trials?

Across its clinical program, TRAVATAN trials have enrolled a total of 502 participants. That enrollment comes from the completed Phase 3 long-term safety study NCT00051168, which included adults aged 18 years and older of all sexes.

What is the dosing schedule for TRAVATAN?

TRAVATAN is dosed once daily. The completed Phase 3 study NCT00051168 was designed as a long-term safety study of once-daily TRAVATAN in patients with open-angle glaucoma or ocular hypertension, and it enrolled 502 participants in the United States.