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INS115644

Phase 1

Ocular Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Jan 21, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00443924Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or GlaucomaPHASE1 COMPLETED 56Mar 1, 2007Apr 1, 2009Jan 21, 2015 -
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Study Endpoints
Primary Endpoints
Safety and tolerability
28 days
Changes in intraocular pressure
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATORArm 1
2EXPERIMENTALArm 2
3EXPERIMENTALArm 3
4EXPERIMENTALArm 4
5EXPERIMENTALArm 5
Interventions
NameTypeDescription
INS115644 Ophthalmic SolutionDRUGOne drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
PlaceboDRUGOne drop of placebo in each eye every 12 hours for three days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma * Have best corrected visual acuity in both eyes of at least +0.5 or better * Have normal endothelial cell counts and morphology Exclusion Criteria: * Are diagnosed with closed angle glauc...

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