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Xalacom

Phase 4

Glaucoma | Small molecule | Ophthalmology |Pfizer, Inc.|Trials Updated: Sep 8, 2021

Xalacom development status

Highest phase Phase 4 (NCT00143208)
Phase scored for PFEPhase 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-BlindCONTROLLED
Total Trials5
Total Enrollment2,544

FDA Designations

No designations recorded

Xalacom clinical trials

Xalacom · 5 trials · 5 indications

Phase 3 5
NCT00383019A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).Glaucoma
COMPLETED300 Analytics
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
NCT00150267A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular HypertensionGlaucoma, Open-Angle
COMPLETED976 Analytics
PHASE3COMPLETED
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
GlaucomaUnlock trial analytics
PHASE3COMPLETED
A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
Open Angle GlaucomaUnlock trial analytics
PHASE3COMPLETED
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
Glaucoma, Open-AngleUnlock trial analytics
PHASE3COMPLETED
Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
Glaucoma, Open AngleUnlock trial analytics
PHASE3COMPLETED
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
Glaucoma, Open-AngleUnlock trial analytics

Study Endpoints

Primary Endpoints

Change of Intraocular Pressure (IOP) From Baseline to Week 8
Baseline to Week 8

Value at Week 8 minus value at baseline

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
Incidence of increase of iris pigmentation
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
occurrence of ocular/periorbital adverse events
occurrence of serious adverse events.

Secondary Endpoints

Change of IOP From Baseline to Week 4
Baseline to Week 4
Number of Subjects With an IOP of <=15 mmHg at Week 8
Week 8
Number of Subjects With an IOP of <=16 mmHg at Week 8
Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XalatanEXPERIMENTAL -
XalacomEXPERIMENTAL -

Interventions

NameTypeDescription
XalatanDRUGlatanoprost 0.005%, one rop once daily in evening
XalacomDRUGlatanoprost 0.005% adn timolol 0.5%, one drop, once daily
TimololDRUG -
unfixed Latanoprost and TimololDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more. Exclusion Criteria: * History of no-response to timolol * History of trabeculectomy * History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

Countries:JapanUnited StatesCanadaChinaAustraliaBelgiumDenmarkFranceGermanyGreeceIrelandItalyNetherlandsSpainSwedenUnited Kingdom
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Frequently asked questions about Xalacom

What is Xalacom used for?

Xalacom is used for the treatment of glaucoma, including open angle glaucoma, and ocular hypertension. It is an ophthalmology product developed by Pfizer, Inc. and has been studied in Phase 3 clinical trials involving patients with these conditions.

Who makes Xalacom?

Xalacom is made by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the developer responsible for the clinical development of Xalacom.

What phase is Xalacom in?

Xalacom is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 program includes four trials, all of which are completed.

What clinical trials is Xalacom in?

Xalacom has been evaluated in four Phase 3 clinical trials. These include NCT00383019, NCT00277498, NCT00219596, and NCT00159653. The trials enrolled a total of 2,244 participants and studied Xalacom in patients with glaucoma or ocular hypertension.

Is Xalacom the same as Xalatan?

Xalacom and Xalatan are not the same. Xalatan is a separate product that was used as a comparator in a Phase 3 trial of Xalacom. Xalacom is a fixed combination therapy, while Xalatan is a single-agent treatment.