Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-weeks, Masked Evaluator, Phase IV Multi-center Study in the US

Study Overview
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Brief Summary
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Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost

Official Title
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A Comparison of Latanoprost (Xalatan) With Travoprost (Travatan) and Bimatoprost (Lumigan) in Patients With Elevated Intraocular Pressure. A Twelve-week, Masked Evaluator, Phase IV, Multicenter Study in the United States. (Xalatan vs Travatan vs Lumigan).

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: latanoprost 0.005% ophthalmic solution
* Drug: Travoprost 004% sterile ophthalmic solution
* Drug: Bimatoprost .03% sterile ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral primary open angle glaucoma (POAG), exfoliative glaucoma, pigmentary glaucoma or ocular hypertension (glaucoma is defined as either visual fields defect or glaucomatous changes of the optic nerve head in association with elevated intraocular pressure. Ocular hypertension is defined as IOP ≥ 21 mmHg at diagnosis). Is currently receiving (at the screen visit) or has received topical monotherapy or dual therapy (within the past 6 months) for POAG or ocular hypertension. Required washout periods are 4 weeks for -adrenergic antagonists, prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) and 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors, prior to the baseline visit. Mean 8 AM IOP ≥ 23 mmHg at the baseline visit for all patients. Patients should be assigned treatment only after the 8 PM IOP is obtained. Visual acuity (best corrected) equal to or better than 20/200 (Snellen). ETDRS charts may be used and converted to Snellen units. Informed Consent: Signed Informed Consent is obtained at the screen visit. Able to adhere to treatment/visit planUnilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.) IOP of 22mmHg or higher obtained during the pre-study period. Exclusion Criteria: Ocular conditions Closed/barely open anterior chamber angle or history of acute angle closure. (Patients who are diagnosed with POAG after a successful peripheral iridotomy may be enrolled). History of ALT (Argon Laser Trabeculoplasty) within 3 months prior to the screen visit (the unlasered eye may be enrolled as the study eye). History of any ocular filtering surgical intervention (the unfiltered eye may be enrolled as the study eye). Ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to screen visit. (Applies to both fellow and study eyes.) Hypersensitivity to benzalkonium chloride or to any other component in latanoprost (Xalatan), travoprost (Travatan) or bimatoprost (Lumigan). Other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement. Other conditions Use of systemic medication known to affect IOP (i.e., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers, or corticosteroids), unless the patient and the medication dosage have been stable for three months prior to the screen visit and the dosage is not expected to change during the study. Women Women of childbearing potential (WOCBP) who are not using contraceptive methods. Women of childbearing potential are defined as women who are not surgically sterile or not postmenopausal (at least 12 months without a menstrual period). Contraception is defined as abstinence, having a vasectomized partner, or the ongoing use of approved oral, injectable or implanted contraceptives, a barrier method, or an IUD. Pregnancy. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the screen visit and baseline visit. Nursing mothers General Use of any investigational medication within 30 days prior to screen visit.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Latanoprost<br> | Drug: latanoprost 0.005% ophthalmic solution<br>* One drop in the evening in the affected eye(s) at 8:00pm<br>* Other names: Xalatan;|
| Active Comparator: Travoprost<br> | Drug: Travoprost 004% sterile ophthalmic solution<br>* One drop in the evening in the affected eye(s) at 8:00pm<br>* Other names: Travatan;|
| Active Comparator: Bimatoprost<br> | Drug: Bimatoprost .03% sterile ophthalmic solution<br>* One drop in the evening in the affected eye(s) at 8:00pm<br>* Other names: Lumigan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period. |  | 12 weeks | 
| The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the safety variables within and between all treatment groups over 12 weeks |  | 12 weeks | 
| The mean change since baseline of Week 12 IOP measured at the time of trough (8:00PM) drug effect. The mean percentage change since baseline of diurnal IOP at Week 12. |  | 12 weeks | 
| The mean change since baseline of Week 12 IOP measured at the times of peak (8:00AM) and trough (8:00PM) drug effects evaluated by race. The percentage of patient withdrawals from the study |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, ocular hypertension, latanoprost, travoprost, bimatoprost