Recent Updates
Recently added Catalysts

Nepafenac /ml eye ,

Phase 3

Cataracts | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Nov 18, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment227
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00405730Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and PlaceboPHASE3 COMPLETED 227Nov 1, 2005Jul 1, 2006Nov 18, 20161 France
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Patients with Day 14 Cure
Day 14

Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NepafenacEXPERIMENTALOne drop in the study eye 3 times daily for 23 days
Ketorolac TrometamolACTIVE_COMPARATOROne drop in the study eye 3 times daily for 23 days
Nepafenac VehiclePLACEBO_COMPARATOROne drop in the study eye 3 times daily for 23 days
Interventions
NameTypeDescription
Nepafenac 1mg/ml eye drops, suspensionDRUGOne drop in the study eye 3 times daily for 23 days
Ketorolac Trometamol 5 mg/ml eye drops, solutionDRUGOne drop in the study eye 3 times daily for 23 days
Nepafenac vehicle eye dropsOTHEROne drop in the study eye 3 times daily for 23 days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Under 18. * Other protocol-defined exclusion...

Countries:France
Unlock Eligibility Criteria