Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
* Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
* Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
* Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 years Female subjects of childbearing potential must have negative pregnancy test and practice contraception Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate Subjects able to complete questionnaires and provide informed consent Exclusion Criteria: Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control Subjects wherein the study drugs are contraindicated Subjects who have had intraocular surgery with 6 months (3 months for laser) Subjects with known side effects/allergy or sensitivity to any component of study treatments Subjects with any uncontrolled systemic disease

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: 1<br>brimonidine/timolol Fixed-combination monotherapy | Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination<br>* 1 drop BID in each eye<br>* Other names: Combigan®;|
| Active Comparator: 2<br>dorzolamide/timolol fixed-combination monotherapy | Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination<br>* 1 drop BID in each eye<br>* Other names: Cosopt®;|
| Active Comparator: 3<br>prostaglandin analogue + brimonidine/timolol fixed combination | Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy<br>* 1 drop BID in each eye<br>* Other names: Combigan®;|
| Active Comparator: 4<br>prostaglandin analogue + dorzolamide/timolol fixed combination | Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy<br>* 1 drop BID in each eye<br>* Other names: Cosopt®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean IOP |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerability/comfort measured by Likert scale |  | Month 1 |