Recent Updates
Recently added Catalysts

latanoprost 0.005%

Phase 4

Glaucoma, Primary Open Angle (POAG) | Small molecule | Ophthalmology |Viatris Inc.|Trials Updated: Feb 18, 2021

latanoprost 0.005% development status

Highest phase Phase 4 run by Allergan (NCT00735449)
Phase scored for VTRSPhase 3
Registered trials 8 across 6 sponsors since Dec 2007

latanoprost 0.005% target and mechanism

ModalitySmall molecule

Also known as latanoprost 0.005% ophthalmic solution

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials2
Total Enrollment814

FDA Designations

No designations recorded

latanoprost 0.005% clinical trials

latanoprost 0.005% · 2 trials · 3 indications

Phase 3 2
NCT00230763Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular PressureGlaucoma, Primary Open Angle (POAG)
COMPLETED396 Analytics
NCT00800267A Study of Glaucoma or Ocular Hypertension in Patients Within the United StatesOcular Hypertension
COMPLETED418 Analytics
PHASE3COMPLETED
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure
Glaucoma, Primary Open Angle (POAG)
NCT00230763396
Unlock trial analytics
PHASE3COMPLETED
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Ocular Hypertension
NCT00800267418
Unlock trial analytics

Study Endpoints

Primary Endpoints

A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
after 12 weeks of treatment
The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
6 months
Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
6 months

Secondary Endpoints

Absolute and relative IOP change after 4 and 12 weeks of treatment
week 4 and 12
Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,
week 12
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol
6 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTAL -
ProcedureOTHER -
Fixed combination of latanoprost 0.005% and timolol 0.5%EXPERIMENTAL -
latanoprost 0.005%ACTIVE_COMPARATOR -
Timolol - 0.5%ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GSS questionnairePROCEDURED0, D30 and D84
IOPPROCEDURED0, D30 and D84
LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATIONDRUGin the evening during 84 days
Visual acuityPROCEDURED0 and D84
latanoprost 0.005%DRUGplacebo in the morning and latanoprost .005% in the evening
fixed combination latanoprost-timololDRUGone drop in the morning and placebo in the evening
timolol 0.5%DRUGone drop in the morning and evening
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites102

Inclusion Criteria: * Male or female patients, * Aged \> than equal to 18 years, * Patient presenting with an OHT or OAG with an IOP � 21 mmHg, * Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to t...

Countries:FranceUnited States
Unlock Eligibility Criteria

Explore more on BiopharmaWatch

Viatris Inc. (VTRS)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with LCompanies A to ZEvery biotech and pharma company we track