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i. Fixed combination of latanoprost 0.005% and timolol 0.5%

Phase 3

Ocular Hypertension | Small molecule | Ophthalmology |Viatris Inc.|Trials Updated: Feb 21, 2021

i. Fixed combination of latanoprost 0.005% and timolol 0.5% development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment436

FDA Designations

No designations recorded

i. Fixed combination of latanoprost 0.005% and timolol 0.5% clinical trials

i. Fixed combination of latanoprost 0.005% and timolol 0.5% · 1 trial · 3 indications

Phase 3 1
NCT00856622A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In PatientsOcular Hypertension
COMPLETED436 Analytics
PHASE3COMPLETED
A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients
Ocular Hypertension
NCT00856622436
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Study Endpoints

Primary Endpoints

To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
6 months

Secondary Endpoints

To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26
6 Months
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
6 Months
To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
6 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fixed combination of latanoprost 0.005% and timolol 0.5%EXPERIMENTAL -
timolol 0.5% ophthalmic solutionACTIVE_COMPARATORone drop in the morning and evening
latanoprost 0.005% ophthalmic solutionACTIVE_COMPARATORplacebo in the morning and latanoprost .005% in the evening

Interventions

NameTypeDescription
i. Fixed combination of latanoprost 0.005% and timolol 0.5%DRUGone drop in the morning and placebo in the evening
timolol 0.5% ophthalmic solutionDRUGone drop in the morning and evening
latanoprost 0.005% ophthalmic solutionDRUGplacebo in the morning and latanoprost .005% in the evening
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patient...

Countries:Germany
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Competitive Landscape -Ocular Hypertension 11 trials

CompanyTickerTrialsLead PhaseDrugs
SpyGlass Pharma, Inc.SGP5PHASE3Bimatoprost System, BIM-DRS
Amneal Pharmaceuticals, Inc. Class AAMRX1PHASE3Bimatoprost ophthalmic solution
AbbVie, Inc.ABBV1PHASE1AGN-193408
Regeneron Pharmaceuticals, Inc.REGN1PHASE1REGN22530
Glaukos CorpGKOS2 - Travoprost
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