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

Phase 4

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: 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

• Registration Number: NCT02325518
• Lead Sponsor: Alcon, a Novartis Company

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Results First Submitted: 2016-10-13
• Results First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Results First Posted: 2016-12-08
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRI/TIM	Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension	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.
BRI/TIM	Subject's habitual PGA monotherapy	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.
DOR/TIM	Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution	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.
DOR/TIM	Subject's habitual PGA monotherapy	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.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM	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

Name	Time	Method
Least Squares Mean Change From Baseline in IOP at 9 AM	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.

Trial Locations

Locations (1)

Contact Alcon Japan Ltd. for Trial Locations; 🇯🇵 Tokyo, Japan