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

• ClinicalTrials.gov Identifier: NCT02325518
• Recruitment Status: Completed
• First Posted: December 25, 2014
• Results First Posted: December 8, 2016
• Last Update Posted: December 8, 2016
• Sponsor: Alcon, a Novartis Company
• Information provided by (Responsible Party): Alcon Research ( Alcon, a Novartis Company )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension	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	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 218 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: 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
• Study Start Date: December 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

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 Name: 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: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution; Other Name: COSOPT®; Drug: Subject's habitual PGA monotherapy

Outcome Measures

Primary Outcome Measures :

1. Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM [ Time Frame: Baseline (Day 0), Week 4, Week 8 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.

Secondary Outcome Measures :

1. Least Squares Mean Change From Baseline in IOP at 9 AM [ Time Frame: Baseline (Day 0), Week 4, Week 8 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Japan

Contact Alcon Japan Ltd. for Trial Locations

Tokyo, Japan, 107-0052

Sponsors and Collaborators

Alcon, a Novartis Company

Investigators

• Study Director: Clinical and Regulatory Affairs; Alcon Japan, Ltd.

More Information

• Responsible Party: Alcon, a Novartis Company
• ClinicalTrials.gov Identifier: NCT02325518
• Other Study ID Numbers: ALJ-P2014-1; UMIN000017569 ( Registry Identifier: UMIN )
• First Posted: December 25, 2014
• Results First Posted: December 8, 2016
• Last Update Posted: December 8, 2016
• Last Verified: October 2016

Keywords provided by Alcon Research ( Alcon, a Novartis Company ):

Open-angle glaucoma (OAG); Ocular hypertension (OHT); AZORGA®; COSOPT®

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Dorzolamide; Ophthalmic Solutions; Maleic acid; Brinzolamide; Pharmaceutical Solutions; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors