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Xalacom

Phase 4

Open Angle Glaucoma | Small molecule | Ophthalmology |Viatris Inc.|Trials Updated: Feb 21, 2021

Xalacom development status

Highest phase Phase 4 (NCT00143208)
Phase scored for VTRSPhase 3
Registered trials 10 across 3 sponsors since Aug 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment1,268

FDA Designations

No designations recorded

Xalacom clinical trials

Xalacom · 3 trials · 4 indications

Phase 3 3
NCT00277498A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With GlaucomaOpen Angle Glaucoma
COMPLETED528 Analytics
NCT00159653A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With GlaucomaGlaucoma, Open-Angle
COMPLETED500 Analytics
NCT00219596Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular HypertensionGlaucoma, Open Angle
COMPLETED240 Analytics
PHASE3COMPLETED
A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
Open Angle Glaucoma
NCT00277498528
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PHASE3COMPLETED
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
Glaucoma, Open-Angle
NCT00159653500
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PHASE3COMPLETED
Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
Glaucoma, Open Angle
NCT00219596240
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Study Endpoints

Primary Endpoints

The mean IOP measurements obtained in the study eye at each time point.
The mean IOP measurements obtained in the study eye at each time point
To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension

Secondary Endpoints

To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
XalacomDRUG -
XalatanDRUG -
TimololDRUG -
unfixed Latanoprost and TimololDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: * Closed/ barely open anterior chamber...

Countries:United StatesCanadaChina
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Competitive Landscape -Open-Angle Glaucoma 9 trials (matched to "Open Angle Glaucoma")

Top 3 of 5 competitors

CompanyTickerTrialsLead PhaseDrugs
Glaukos CorpGKOS3PHASE4Travoprost Intraocular, high elution
Amneal Pharmaceuticals, Inc. Class AAMRX1PHASE4Bimatoprost ophthalmic solution
AbbVie, Inc.ABBV1PHASE4bimatoprost
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