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Travoprost 0.004% Eye

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution

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

Clinical trial landscape

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")