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Xalacom

Phase 3

Glaucoma, Open Angle | Small molecule | Ophthalmology |Pfizer, Inc.|Last Updated: Feb 21, 2021

Success Probability

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Xalacom · 4 trials · 4 indications

Phase 3 4
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 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

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

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 StatesCanadaChinaAustraliaBelgiumDenmarkFranceGermanyGreeceIrelandItalyNetherlandsSpainSwedenUnited Kingdom
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Frequently asked questions about Xalacom

What is Xalacom used for?

Xalacom is used for the treatment of open-angle glaucoma and ocular hypertension. It is an ophthalmic medication developed by Pfizer, Inc. for conditions involving elevated pressure in the eye. The drug is administered as eye drops and is intended to lower intraocular pressure in patients with these conditions.

Who makes Xalacom?

Xalacom is developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. Pfizer is a multinational pharmaceutical company that has conducted clinical trials for Xalacom in the treatment of open-angle glaucoma and ocular hypertension.

What phase is Xalacom in?

Xalacom is in Phase 3 clinical development. It has completed multiple Phase 3 trials, including postmarketing safety studies and randomized comparisons of dosing regimens. The drug is investigational and remains in clinical development for the treatment of open-angle glaucoma and ocular hypertension.

What clinical trials is Xalacom in?

Xalacom has been studied in several completed Phase 3 trials, including NCT00150267, a 5-year postmarketing safety study with 976 patients, and NCT00159653, a 12-week randomized comparison of evening dosing with 500 patients. Other trials include NCT00219596 and NCT00277498, both evaluating Xalacom in patients with glaucoma.

Is Xalacom the same as latanoprost and timolol combination?

Xalacom is a fixed combination product containing latanoprost and timolol. One clinical trial, NCT00219596, compared Xalacom with an unfixed combination of latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension, indicating that Xalacom combines these two active ingredients in a single formulation.

How does Xalacom work?

Xalacom works by combining two active ingredients, latanoprost and timolol, to lower intraocular pressure in patients with glaucoma. Latanoprost increases the outflow of aqueous humor, while timolol reduces its production. This dual mechanism helps manage elevated eye pressure in conditions like open-angle glaucoma.