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Pilocarpine , Dose 1

Phase 2

Dry Eye Disease | Small molecule | Ophthalmology |Glaukos Corporation|Last Updated: Jul 12, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment226
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05119920Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye DiseasePHASE2 COMPLETED 226Jan 3, 2022Jul 27, 2022Jul 12, 202319 United States
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Study Endpoints
Primary Endpoints
Mean change from baseline in the VAS score at Day 28 visit.
Baseline and Day 28

Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)

Mean change from baseline in Fluorescein Staining at the Day 28 visit.
Baseline and Day 28
Secondary Endpoints
Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits
Baseline and Days 4, 8, and 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pilocarpine Ophthalmic Topical Cream, Dose 1EXPERIMENTALPilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2EXPERIMENTALPilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3EXPERIMENTALPilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical CreamPLACEBO_COMPARATORPlacebo Ophthalmic Topical Cream
Interventions
NameTypeDescription
Pilocarpine Ophthalmic Topical Cream, Dose 1DRUGPilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 2DRUGPilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 3DRUGPilocarpine Ophthalmic Topical Cream, Dose 3
Placebo Ophthalmic Topical CreamDRUGPlacebo Ophthalmic Topical Cream
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Male or female, 18 years of age or older at the Screening Visit * Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form * Diagnosis of dry eye Exclusion Criteria: * Sensitivity or known allergy to pilocarpine or any of the other e...

Countries:United States
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