Recent Updates
Recently added Catalysts

latanoprost

Phase 2

Primary Open Angle Glaucoma | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Feb 2, 2021

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment282
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01379144A Study Comparing The Efficacy, Safety And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma And Ocular HypertensionPHASE2 COMPLETED 282Jan 1, 2003Apr 1, 2003Feb 2, 202125 Australia, Czechia +6
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
Baseline and Day 28
Secondary Endpoints
The change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline across all clinic visits; comparisons were made by separate analyses for each time point and visit.
Baseline and Day 28
The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).
Baseline and Day 28
Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.
Baseline and Day 28
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
latanoprost 75 ugEXPERIMENTAL -
latanoprost 100 ugEXPERIMENTAL -
latanoprost 125 ugEXPERIMENTAL -
latanoprost 50 ugACTIVE_COMPARATOR -
Interventions
NameTypeDescription
latanoprost 75 ugDRUGEligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
latanoprost 100 ugDRUGEligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
latanoprost 125 ugDRUGEligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
latanoprost 50 ugDRUGEligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Male or female, 18 years of age or older. * Primary open angle glaucoma (POAG) or ocular hypertension (OHT) requiring unilateral or bilateral administration of intraocular pressure (IOP) lowering treatment, including patients who were naïve to IOP lowering treatment. * IOP bet...

Countries:AustraliaCzechiaFranceGreecePakistanPortugalThailandUnited Kingdom
Unlock Eligibility Criteria