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

NCT ID: NCT02325518

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension

Intervention Type: DRUG

Subject's habitual PGA monotherapy

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution

Intervention Type: DRUG

Subject's habitual PGA monotherapy

Intervention Type: DRUG

Interventions

Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension

Intervention Type: DRUG

Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution

Intervention Type: DRUG

Subject's habitual PGA monotherapy

Intervention Type: DRUG

Other Intervention Names

AZORGA®; COSOPT®

Eligibility 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.

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon, a Novartis Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical and Regulatory Affairs

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

Contact Alcon Japan Ltd. for Trial Locations

Tokyo, , Japan

Countries

Japan

Other Identifiers

UMIN000017569

Identifier Type: REGISTRY

Identifier Source: secondary_id

ALJ-P2014-1

Identifier Type: -

Identifier Source: org_study_id