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Travatan

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment502
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00051168A Long-term Safety Study of Once-daily TravatanPHASE3 COMPLETED 502Jan 1, 2006 -Oct 7, 20111 United States
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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 — 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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