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Travoprost 0.004% PQ

Phase 3

Pediatric Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 23, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment184

FDA Designations

No designations recorded

Clinical trial landscape

Travoprost 0.004% PQ · 1 trial · 3 indications

Phase 3 1
NCT01652664Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma PatientsPediatric Glaucoma
COMPLETED184 Analytics
PHASE3COMPLETED
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Pediatric GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline in IOP at Month 3
Baseline (Day 0), Month 3

IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TravoprostEXPERIMENTALTravoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months
TimololACTIVE_COMPARATORTimolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months

Interventions

NameTypeDescription
Travoprost 0.004% PQ ophthalmic solutionDRUG -
Timolol, 0.5% or 0.25% ophthalmic solutionDRUGPatients 2 months to \< 3 years of age received 0.25%
Travoprost VehicleDRUGInactive ingredients used to maintain masking
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Eligibility Criteria

Age Range2 Months to 17 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of pediatric glaucoma or ocular hypertension. * Qualifying mean IOP at the Eligibility Visit in at least one eye. * Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedur...

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Frequently asked questions about Travoprost 0.004% PQ

What is Travoprost 0.004% PQ used for in pediatric glaucoma?

Travoprost 0.004% PQ is an investigational small molecule being studied for the treatment of pediatric glaucoma, specifically to lower elevated intraocular pressure (IOP) in pediatric patients. It is a prostaglandin analog ophthalmic solution developed by Alcon Inc. (NYSE: ALC) and is currently in Phase 3 clinical development.

What does Travoprost 0.004% PQ target?

Travoprost 0.004% PQ is a prostaglandin analog that works by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure. It is being evaluated for its ability to lower elevated IOP in pediatric patients with glaucoma or ocular hypertension.

Who makes Travoprost 0.004% PQ?

Travoprost 0.004% PQ is being developed by Alcon Inc., a pharmaceutical company specializing in eye care. Alcon is publicly traded on the New York Stock Exchange under the ticker symbol ALC.

What phase is Travoprost 0.004% PQ in?

Travoprost 0.004% PQ is in Phase 3 clinical development for pediatric glaucoma. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, with results not yet reported.

What clinical trials is Travoprost 0.004% PQ in?

Travoprost 0.004% PQ has been studied in one completed Phase 3 trial, NCT01652664, which compared it to timolol (0.5% or 0.25%) in pediatric glaucoma patients. The trial enrolled 184 participants aged 2 months and older and was double-blind and active-controlled.

Is Travoprost 0.004% PQ the same as Travoprost?

Travoprost 0.004% PQ is a specific formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. The 'PQ' designation indicates a preservative-free formulation, which may be used to avoid preservative-related side effects. It is being studied specifically for pediatric glaucoma.