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Emulsion

Phase 3

Keratoconjunctivitis Sicca | Small molecule | Immunology |AbbVie Inc.|Last Updated: May 30, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00025818Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromePHASE3 COMPLETED 290May 1, 2001Mar 1, 2003May 30, 201117 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Ophthalmic EmulsionDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

* Eighteen years or older * Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria: * Diagnosis of autoimmune disorder * Female 65 years of age or older

Countries:United States
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