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Travoprost 0.004% Eye

Phase 3

Open Angle Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Trials Updated: Apr 6, 2012

Travoprost 0.004% Eye target and mechanism

Molecular targetPTGFR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment371

FDA Designations

No designations recorded

Travoprost 0.004% Eye clinical trials

Travoprost 0.004% Eye · 1 trial · 2 indications

Phase 3 1
NCT00848536Efficacy Study of Travoprost APS Versus TRAVATANOpen Angle Glaucoma
COMPLETED371 Analytics
PHASE3COMPLETED
Efficacy Study of Travoprost APS Versus TRAVATAN
Open Angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Intraocular Pressure at 9:00 am
3 months (measured at 9:00 am)

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Mean Intraocular Pressure at 11:00 am
3 months (measured at 11:00 am)

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Mean Intraocular Pressure at 4:00 pm
3 months (measured at 4:00 pm)

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TRAVATAN APSEXPERIMENTALOne drop once daily in the evening for 3 months
TRAVATANACTIVE_COMPARATOROne drop once daily in the evening for 3 months

Interventions

NameTypeDescription
Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, SolutionDRUGOne drop once daily in the evening for 3 months
Travoprost 0.004% (BAK-preserved) Eye Drops, SolutionDRUGOne drop once daily in the evening for 3 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 18 years of age or older, either gender and any race. * Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). * Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy. * All patients: Mean IOP...

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Competitive Landscape -Open-Angle Glaucoma 9 trials (matched to "Open Angle Glaucoma")

Frequently asked questions about Travoprost 0.004% Eye

What is Travoprost 0.004% Eye used for?

Travoprost 0.004% Eye is used to treat open angle glaucoma, a condition in which elevated pressure inside the eye can damage the optic nerve. It is also studied in ocular hypertension, where eye pressure is higher than normal. The drug is a small molecule therapy delivered as an eye drop solution.

How does Travoprost 0.004% Eye work?

Travoprost 0.004% Eye works as an agonist of PTGFR, the prostaglandin F receptor. By activating this receptor, the drug increases the outflow of aqueous humor from the eye, which helps lower intraocular pressure. This mechanism targets the underlying cause of pressure buildup in open angle glaucoma.

Who makes Travoprost 0.004% Eye?

Travoprost 0.004% Eye is developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company focused on surgical and vision care products. The travoprost 0.004% formulation is part of its ophthalmology portfolio.

What phase is Travoprost 0.004% Eye in?

Travoprost 0.004% Eye is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA for the studied indication. The Phase 3 program includes one completed trial evaluating its efficacy in open angle glaucoma and ocular hypertension.

What clinical trials is Travoprost 0.004% Eye in?

Travoprost 0.004% Eye has been studied in a Phase 3 trial, NCT00848536, titled Efficacy Study of Travoprost APS Versus TRAVATAN. This completed trial enrolled 371 participants with open angle glaucoma or ocular hypertension. It was randomized, double blind, and active controlled, with participants aged 18 years and older.

Is Travoprost 0.004% Eye the same as Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution?

Yes, Travoprost 0.004% Eye is also known as Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution. The POLYQUAD preservation system distinguishes this formulation. Both names refer to the same travoprost 0.004% ophthalmic solution developed by Alcon for open angle glaucoma.