Efficacy Study of Travoprost APS Versus TRAVATAN

Study Overview
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Brief Summary
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A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension

Official Title
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A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
* Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution


Participation Criteria
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Eligibility Criteria
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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 in same eye (at both Eligibility 1 & 2 Visits): ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential not meeting conditions set in the protocol. Severe central visual field loss. Angle Shaffer grade < 2. Cup/disc ratio > 0.8 (horizontal or vertical measurement). Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal). Intraocular surgery or trauma within last 6 months. Any abnormality preventing reliable applanation tonometry. History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study. Allergy/hypersensitivity to study medications. Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit. Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP. Use of any additional topical or systemic ocular hypotensive medication during the study. Therapy with another investigational agent within 30 days prior to the Screening visit. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRAVATAN APS<br>One drop once daily in the evening for 3 months | Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution<br>* One drop once daily in the evening for 3 months<br>|
| Active Comparator: TRAVATAN<br>One drop once daily in the evening for 3 months | Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution<br>* One drop once daily in the evening for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure 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 | 3 months (measured at 9:00 am) | 
| Mean Intraocular Pressure 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 | 3 months (measured at 11:00 am) | 
| Mean Intraocular Pressure 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 | 3 months (measured at 4:00 pm) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OAG, OHT