Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution

Study Overview
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Brief Summary
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The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

Detailed Description
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After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.

Official Title
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The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension
* Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution
* Drug: Subject's habitual PGA monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand the nature of the study and sign informed consent. Diagnosis of open angle glaucoma or ocular hypertension. Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit. Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease. Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure. History of hypersensitivity to any of the excipients of the study medications. Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders. Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye. History of ocular trauma in either eye within 6 months prior to the screening examination. Ocular infection or ocular inflammation in either eye. History of or current clinically significant or progressive retinal disease in either eye. Intraocular surgery in either eye within 6 months prior to the screening examination. Ocular laser surgery in either eye within 3 months prior to the screening examination. Any abnormality preventing reliable applanation tonometry of either eye. Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye. Severe visual field loss in either eye. Use of prohibited medication, as specified in the protocol. Pregnant, lactating, or intending to become pregnant during the study period. Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination. History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study. Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRI/TIM<br>Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. | Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension<br> <br> * Other names: AZORGA®;Drug: Subject's habitual PGA monotherapy<br> <br> |
| Active Comparator: DOR/TIM<br>Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. | Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution<br> <br> * Other names: COSOPT®;Drug: Subject's habitual PGA monotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis. | Baseline (Day 0), Week 4, Week 8 at 11 AM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Change From Baseline in IOP at 9 AM | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis. | Baseline (Day 0), Week 4, Week 8 at 9 AM | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZORGA®, Open-angle glaucoma (OAG), Ocular hypertension (OHT), COSOPT®