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latanoprost

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment282

FDA Designations

No designations recorded

Clinical trial landscape

latanoprost · 2 trials · 3 indications

Phase 2 1Phase 1 1
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 HypertensionPrimary Open Angle Glaucoma
COMPLETED282 Analytics
PHASE2COMPLETED
A 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 Hypertension
Primary Open Angle GlaucomaUnlock trial analytics

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
Plasma latanoprost acid concentrations at steady-state.
2 weeks

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
latanoprost 75 ugEXPERIMENTAL -
latanoprost 100 ugEXPERIMENTAL -
latanoprost 125 ugEXPERIMENTAL -
latanoprost 50 ugACTIVE_COMPARATOR -
1EXPERIMENTAL -

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.
latanoprostDRUGlatanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.
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Eligibility Criteria

Age Range18 Years to 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 KingdomUnited StatesDenmarkItalySouth AfricaSpain
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Frequently asked questions about latanoprost

What is latanoprost used for?

Latanoprost is used for the treatment of primary open angle glaucoma and glaucoma. It is also studied in ocular hypertension. It is an ophthalmic small molecule being developed by Pfizer, Inc. for these conditions.

Who makes latanoprost?

Latanoprost is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The drug is an ophthalmic small molecule intended for glaucoma and primary open angle glaucoma.

What phase is latanoprost in?

Latanoprost is in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 2 trial. The drug is investigational and has not been approved by the FDA.

What clinical trials is latanoprost in?

Latanoprost has been studied in two completed clinical trials. NCT00638742 was a Phase 1 open-label study of latanoprost acid plasma concentrations in pediatric and adult glaucoma patients. NCT01379144 was a Phase 2 study comparing latanoprost 75, 100 and 125 ug/ml to Xalatan in primary open-angle glaucoma and ocular hypertension.

Is latanoprost the same as Xalatan?

Latanoprost is not the same as Xalatan, but Xalatan was used as a comparator in a clinical trial. In NCT01379144, latanoprost at three different concentrations was compared to Xalatan in patients with primary open-angle glaucoma and ocular hypertension.