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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon, a Novartis Company
• Treatments: Brinzolamide; Dorzolamide; Maleic acid; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

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.