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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325518
• Other study ID #: ALJ-P2014-1
• Secondary ID: UMIN000017569
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2014
• Last updated: January 15, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 patient, in the opinion of the investigator, unsuitable for the study.

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension

• Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution

• Subject's habitual PGA monotherapy

Locations

Country	Name	City	State
Japan	Contact Alcon Japan Ltd. for Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in intraocular pressure (IOP) at 11 AM	IOP (fluid pressure inside the eye) will be assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks will be pooled, and a negative change indicates an improvement. One eye (target eye) will be used for the analysis.	Baseline (Day 0), Up to Week 8	No
Secondary	Mean change from baseline in IOP at 9 AM	IOP (fluid pressure inside the eye) will be assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks will be pooled, and a negative change indicates an improvement. One eye (target eye) will be used for the analysis.	Baseline (Day 0), Up to Week 8	No