Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Study Overview
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Brief Summary
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Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

Official Title
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Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%
* Drug: timolol maleate 0.5%
* Drug: latanoprost 0.005%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age Give written informed consent Be in good general health as determined by your doctor Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills) Understand the study instructions, and be able to follow the study instructions; and Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits Exclusion Criteria: Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation History of severe renal or hepatic impairment Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening 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: Combigan ®<br>Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) | Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%<br>* 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.<br>* Other names: Combigan®;Drug: latanoprost 0.005%<br>* 1 drop of latanoprost 0.005% once nightly.<br>* Other names: Xalatan®;|
| Active Comparator: Timolol Maleate 0.5%<br>Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) | Drug: timolol maleate 0.5%<br>* 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.<br>* Other names: Timoptol®;Drug: latanoprost 0.005%<br>* 1 drop of latanoprost 0.005% once nightly.<br>* Other names: Xalatan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) at 10 AM at Week 12 | Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) at 10 AM at Week 6 | Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. | Week 6 | 
| Mean Intraocular Pressure (IOP) at 8 AM at Week 12 | Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye. | Week 12 | 
| Mean Intraocular Pressure (IOP) at 8 AM at Week 6 | Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye. | Week 6 | 
| Number of Subjects With Adverse Events | Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit). | Week 12 |