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INS365

Phase 3

Keratoconjunctivitis Sicca | Small molecule | Other |Merck & Company, Inc.|Last Updated: Oct 2, 2015

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 Enrollment222
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00037661Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry EyePHASE3 COMPLETED 222Apr 1, 2002Mar 1, 2003Oct 2, 2015 -
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
INS365 Ophthalmic SolutionDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months * had intermittent or regular artificial tear use within past 3 months Exclusion Criteria: * had LASIK surgery * had punctal occlusion or cauterization within last 3 months

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