Recent Updates
Recently added Catalysts

Latanoprostene bunod

Phase 3

Glaucoma | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Jul 26, 2018

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical trial landscape

Latanoprostene bunod · 2 trials · 3 indications

Phase 3 1Phase 1 1
NCT01895972Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHTGlaucoma
COMPLETED130 Analytics
PHASE3COMPLETED
Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHT
GlaucomaUnlock trial analytics
Study Endpoints
Primary Endpoints
Change From Baseline in Intraocular Pressure
Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52

Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.

Clinical Safety
1 year

Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with \>/=1 ocular AE Specifics of AEs are captured in the AE section.

intraocular pressure (IOP)
Visit 3 (Day 14/15)

Efficacy of latanoprostene bunod dosed QD in reducing IOP from baseline. IOP to be measured at multiple time points at visit 3.

Secondary Endpoints
Blood levels following a single dose
12 hours
Blood levels following multiple dosing
14 days
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Latanoprostene BunodEXPERIMENTALLatanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Interventions
NameTypeDescription
Latanoprostene bunodDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma \[NTG\],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes. * Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day ...

Countries:United States
Unlock Eligibility Criteria