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Latanoprost

Phase 1

Open Angle Glaucoma -Ocular Hypertension | Small molecule | Ophthalmology |Sanofi|Last Updated: Apr 27, 2016

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Latanoprost · 1 trial · 1 indication

Phase 1 1
NCT0253115228-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular HypertensionOpen Angle Glaucoma -Ocular Hypertension
COMPLETED54 Analytics
PHASE1COMPLETED
28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension
Open Angle Glaucoma -Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events (including local tolerance and ophthalmological examinations)
From screening (Day -42) up to approximately Day 39

Secondary Endpoints

Assessment of IOP using Goldman applanation tonometry
From screening (Day -42) up to approximately Day 39
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR366234 (Dose 1)EXPERIMENTALA low dose of SAR366234 will be administered 2 drops per eye per day for 28 days
SAR366234 (Dose 2)EXPERIMENTALA medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 3)EXPERIMENTALA medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days
SAR366234 (Dose 4)EXPERIMENTALA high dose of SAR366234 will be administered 1 drop per eye per day for 28 days
SAR366234 (Dose 5)EXPERIMENTALA high dose of SAR366234 will be administered 2 drops per eye per day for 28 days
LatanoprostACTIVE_COMPARATORA dose of Latanoprost will be administered 1 drop per eye per day for 28 days

Interventions

NameTypeDescription
LatanoprostDRUG -
SAR366234DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion criteria: * Male or female patients ≥18 years of age. * Patients diagnosed with OAG (including pseudoexfoliation and pigment dispersion syndromes and patients with a history of narrow angle closure with a patent peripheral iridotomy) or OHT. * Documented intraocular pressure (IOP) fulfill...

Countries:United States
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Frequently asked questions about Latanoprost

What is Latanoprost used for?

Latanoprost is used for open angle glaucoma and ocular hypertension. It is an ophthalmology drug being developed by Sanofi as a small molecule. It is currently in Phase 1 clinical development, meaning it is investigational and not yet approved.

Who makes Latanoprost?

Sanofi (ticker: SNY) is developing Latanoprost. The drug is a small molecule in the ophthalmology therapeutic area, intended for open angle glaucoma and ocular hypertension. It is currently in Phase 1 clinical development.

What phase is Latanoprost in?

Latanoprost is in Phase 1 clinical development. It is an investigational drug for open angle glaucoma and ocular hypertension. It has completed one Phase 1 trial, and it is not yet approved for any use.

What clinical trials is Latanoprost in?

Latanoprost has one completed clinical trial, NCT02531152, a 28-day repeated topical study evaluating safety and activity of 5 escalating dose levels of SAR366234 and one dose of Latanoprost in patients with open angle glaucoma or ocular hypertension. The trial enrolled 54 participants in the United States.

Is Latanoprost the same as SAR366234?

No, Latanoprost is not the same as SAR366234. In the clinical trial NCT02531152, both drugs were studied separately: SAR366234 was given at 5 escalating dose levels, while Latanoprost was given at one dose. They are distinct investigational drugs.