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DA-6034

Phase 1

Dry Eye Syndrome | Small molecule | Ophthalmology |Co-Diagnostics, Inc.|Last Updated: Oct 1, 2014

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 Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01162954Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy VolunteersPHASE1 COMPLETED -Sep 1, 2008Mar 1, 2009Oct 1, 20141 South Korea
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Study Endpoints
Primary Endpoints
Ocular symptomatology, ophthalmologic tests
Single dose: up to 5 days, Multiple dose: up to 15 days
Secondary Endpoints
Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests
Single dose: up to 10 days, Multiple dose: up to 20 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DA-6034EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DA-6034DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range20 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 20-50 year-old healthy subjects Exclusion Criteria: * Presence or history of dry eye or other ocular or systemic diseases * Corrected visual acuity less than 20/40 in either eye at the screening * Any eye surgery or laser eye surgery within the past six months * Intraocular ...

Countries:South Korea
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