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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension; Drug: Subject's habitual PGA monotherapy; Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 107-0052
    • Contact Alcon Japan Ltd. for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRI/TIM; 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; Other Names: AZORGA®; Drug: Subject's habitual PGA monotherapy
Active Comparator: DOR/TIM; 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: Subject's habitual PGA monotherapy; Drug: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution; Other Names: COSOPT®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Clinical and Regulatory Affairs, Alcon Japan, Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Open-angle glaucoma (OAG); Ocular hypertension (OHT); AZORGA®; COSOPT®
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Pharmaceutical Solutions; Timolol; Dorzolamide; Ophthalmic Solutions; Maleic acid; Brinzolamide
• Other Study ID Numbers: ALJ-P2014-1; UMIN000017569 (Registry Identifier: UMIN)