Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension; Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution; Subject's habitual PGA monotherapy
Intervention MeSH terms: Timolol; Dorzolamide; Ophthalmic Solutions; Maleic acid; Brinzolamide
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 218.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma (OAG); Ocular hypertension (OHT); AZORGA®; COSOPT®

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.
    

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.

          -  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.