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Timolol

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

Timolol · 4 trials · 4 indications

Phase 3 4
NCT00716859A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.Glaucoma
COMPLETED139 Analytics
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
NCT00751049A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United KingdomOcular Hypertension
COMPLETED294 Analytics
NCT00751062A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within ScandinaviaOpen Angle Glaucoma
COMPLETED267 Analytics
PHASE3COMPLETED
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
GlaucomaUnlock trial 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 HypertensionUnlock trial analytics
PHASE3COMPLETED
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
Ocular HypertensionUnlock trial analytics
PHASE3COMPLETED
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia
Open Angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
Baseline, Week 12

Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.

To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
6 months
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment
6 mos
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.
6 mos

Secondary Endpoints

Reduction From Baseline in Mean IOP at Week 1
Baseline, Week 1
Reduction From Baseline in Mean IOP at Week 4
Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)
Baseline, Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TimololACTIVE_COMPARATOR -
latanoprostEXPERIMENTAL -
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
PhXA41EXPERIMENTAL -

Interventions

NameTypeDescription
TimololDRUGTimolol 0.5% dosed twice-daily
latanoprostDRUGLatanoprost 0.005% ophthalmic solution dosed once-daily
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
PhXA41DRUGOne drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
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Eligibility Criteria

Age Range36 Weeks to 18 Years
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Male or female of 18 years of age or under * Diagnosis of glaucoma * IOP of 22 mmHg or above in at least 1 eye Exclusion Criteria: * Require surgery for acute angle closure * Have had prior cyclodestructive procedures * Have a history of ocular trauma or surgery in either ey...

Countries:United StatesBelgiumColombiaCzechiaFranceGermanyIndiaItalyPhilippinesPolandPortugalRomaniaRussiaSerbiaSlovakiaSloveniaSouth AfricaSpainUkraineUnited KingdomDenmarkFinlandNorwaySweden
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Frequently asked questions about Timolol

What is Timolol used for?

Timolol is used for the treatment of glaucoma, ocular hypertension, and open angle glaucoma. It is an ophthalmic medication being developed by Pfizer, Inc. for these conditions, which involve elevated pressure within the eye that can damage the optic nerve.

Who makes Timolol?

Timolol is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 3 clinical development for the treatment of glaucoma and related eye conditions.

What phase is Timolol in?

Timolol is in Phase 3 clinical development. It is an investigational drug for the treatment of glaucoma, ocular hypertension, and open angle glaucoma. It has not been approved by regulatory authorities and remains under clinical investigation.

What clinical trials is Timolol in?

Timolol has been studied in several completed Phase 3 trials, including NCT00716859 in pediatric subjects with glaucoma, NCT00751049 in patients with open angle glaucoma or ocular hypertension in the UK, NCT00751062 in patients in Scandinavia, and NCT00856622 in Germany.

How does Timolol work?

Timolol is a beta-blocker that works by reducing the production of aqueous humor in the eye, thereby lowering intraocular pressure. This mechanism helps to treat conditions like glaucoma and ocular hypertension by decreasing the pressure that can damage the optic nerve.

What is the development status of Timolol?

Timolol is in Phase 3 clinical development, with all completed trials showing it is being studied for glaucoma, ocular hypertension, and open angle glaucoma. It is an investigational small molecule developed by Pfizer, Inc., and is not yet approved for commercial use.