Clinical trial NCT02325518: Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma (OAG)
Ocular hypertension (OHT)
AZORGA®
COSOPT®
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-12-25
Enrollment: 218
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM
timeFrame: Baseline (Day 0), Week 4, Week 8 at 11 AM
Secondary outcomes:
measure: Least Squares Mean Change From Baseline in IOP at 9 AM
timeFrame: Baseline (Day 0), Week 4, Week 8 at 9 AM
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon Japan Ltd. for Trial Locations
Study officials:
affiliation: Alcon Japan, Ltd.
name: Clinical and Regulatory Affairs
role: STUDY_DIRECTOR
References: