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Carboxymethylcellulose and Glycerin

Phase 2

Dry Eye | Small molecule | Ophthalmology |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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment286
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00243711A Multi-Center Randomized Study to Evaluate the Efficacy and Safety of an Investigational Lubricant Eye DropPHASE2 COMPLETED 286Sep 1, 2005Apr 1, 2006May 30, 20111 United States
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Study Endpoints
Primary Endpoints
Dry Eye Symptoms
Secondary Endpoints
Ocular surface damage, tear stability, tear production
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Carboxymethylcellulose sodium and GlycerinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mild, Moderate, or Severe Dry Eye Symptoms and current eye drop use; * Reduced tear stability or tear production Exclusion Criteria: * NONE

Countries:United States
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