DuoTrav APS Versus XALACOM® in Ocular Surface Health

Study Overview
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Brief Summary
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To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health 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: DuoTrav APS
* Drug: Xalacom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age. Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study. Must have had IOP controlled with mono-therapy using XALACOM for at least 1 continuous month prior to Visit 1. Women of childbearing potential must meet all specific conditions at Visit 1: Exclusion Criteria: Any abnormality preventing reliable applanation tonometry in the study eye(s). Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams that may preclude the safe administration of test article or safe participation in this study. Dry eye or KCS which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, within 1 year prior to Visit1 Any other ocular laser surgery in either eye within 3 months Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1. History of other progressive retinal or optic nerve disease. Severe central visual field loss in either eye based upon the clinical judgment of the investigator. Any history of, or current evidence of, infectious or inflammatory ocular conditions Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination. History or evidence of corneal transplant or transplant variant procedures Patients with suspected or diagnosed Sjogren's syndrome. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease. History of spontaneous or current hypoglycemia or uncontrolled diabetes. History of or current severe allergic rhinitis and bronchial hyper reactivity. Intolerance/hypersensitivity to any component of the medication Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study. Use of ocular medications other than XALACOM® within 7 days Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.

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: 1<br>DuoTrav APS | Drug: DuoTrav APS<br>* travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily<br>|
| Active Comparator: 2<br>Xalacom | Drug: Xalacom<br>* XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline (Day 0) in Ocular Surface Disease at the end of the treatment period (Day 90) |  | Visits 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with a corneal fluorescein staining score of 0 at the end of the treatment period (Day 90) |  | Visit 3 (Day 90) | 

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