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Latanoprost

Phase 1

Glaucoma | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Mar 14, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Latanoprost · 1 trial · 1 indication

Phase 1 1
NCT02622334A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).Glaucoma
COMPLETED45 Analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Up to 12 weeks
Changes in vital signs, electrocardiogram (ECG), opthalmologic assessments, and clinical laboratory results
Up to 12 weeks
Change in mean IOP after 7 days treatment vs baseline: change from baseline for RO5093151 and latanoprost and difference in change from baseline between RO5093151 and latanoprost
Baseline (Day 1) and Day 8

Secondary Endpoints

Change in IOP at matched clock-times after 7 days of treatment vs baseline (diurnal IOP) and between RO5093151 and latanoprost
Baseline and Day 8
Maximum observed plasma concentration (Cmax)
Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
Time to maximum observed plasma concentration (Tmax)
Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part AEXPERIMENTALParticipants will receive up to 3 multiple ascending dose levels with the starting dose of 0.1% RO5093151 (topical ocular instillation) and sequentially 0.5% and 1% RO5093151 doses or placebo (3:1, active:placebo) twice a day (BID) on Day 1 and once a day (QD) for 6 days.
Part BEXPERIMENTALParticipants will receive highest feasible dose (HFD) or maximum tolerated dose (MTD) of RO5093151 from Part A or 0.005% latanoprost (topical ocular instillation) once daily for 7 days.

Interventions

NameTypeDescription
LatanoprostDRUGLatanoprost is a ophthalmic solution, available in dose strength as 0.005%.
PlaceboDRUGMatching placebo formulation will be administered in Part A.
RO5093151DRUGRO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG) in at least one eye (qualifying eye) as determined by the Investigator at screening or based on a reliable and documented assessment done within the last 6 months prior to screening provided that no p...

Countries:United StatesSingapore
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Frequently asked questions about Latanoprost

What is Latanoprost used for in Glaucoma?

Latanoprost is an investigational small molecule being studied for the treatment of glaucoma. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated in patients with primary open angle glaucoma or ocular hypertension.

Who makes Latanoprost?

Latanoprost is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this drug for the treatment of glaucoma, and it is currently in Phase 1 development.

What phase is Latanoprost in?

Latanoprost is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with glaucoma.

What clinical trials is Latanoprost in?

Latanoprost has one completed clinical trial, NCT02622334, which was a Phase 1 study in patients with primary open angle glaucoma or ocular hypertension. The trial enrolled 45 participants and was conducted in the United States and Singapore. It was a randomized, double-blind, controlled study.

Is Latanoprost the same as RO5093151?

Yes, Latanoprost is also known as RO5093151. The clinical trial NCT02622334 investigated RO5093151, which is the same drug as Latanoprost. This alternative name may appear in scientific literature and clinical trial registries.