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Systane Ultra eyedrops

Phase 3

Xerophthalmia | Small molecule | Other |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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00796926Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian EyesPHASE3 COMPLETED 30Jul 1, 2009Nov 1, 2010Oct 7, 20111 Singapore
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Study Endpoints
Primary Endpoints
Visual Analog Score (VAS)
6 weeks

Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum

Secondary Endpoints
Corneal Fluorescein Staining Score
6 weeks
Tear Break Up Time (TBUT)
6 weeks
Schirmer I Reading
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Systane UltraEXPERIMENTALUsed four times a day topically to each eye
RefreshACTIVE_COMPARATORUsed four times a day topically to each eye
Interventions
NameTypeDescription
Systane Ultra eyedropsDRUGFour times a day
Refresh eye dropsDRUGFour times a day
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Eligibility Criteria
Age Range40 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subject age is between 40 and 65 years old. 2. Corneal fluorescein staining present in at least one/five sectors of at least one cornea 3. At least one question out of 6 questions on dry eye symptom present often or all the time. based on the Salisbury Eye study by Oliver...

Countries:Singapore
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