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Travoprost APS 40 micrograms/ml eye

Phase 3

Open Angle Glaucoma | Small molecule | Cardiovascular |Alcon Inc.|Last Updated: Jul 15, 2014

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment434
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00892762Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface HealthPHASE3 COMPLETED 434Jun 1, 2009May 1, 2011Jul 15, 2014 -
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Study Endpoints
Primary Endpoints
Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
Day 90
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Travoprost APSEXPERIMENTALTravoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
XALATANACTIVE_COMPARATORLatanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
Interventions
NameTypeDescription
Travoprost APS 40 micrograms/ml eye drop solutionDRUGnon-BAK (benzalkonium chloride) medication
Latanoprost 50 micrograms/ml eye drop solutionDRUGBAK-preserved medication
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye. * Must be willing and able to discontinue use of any topical ocular medication other than the study medication f...

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Competitive Landscape -Open-Angle Glaucoma 9 trials