Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Alcon

Status and phase: Terminated; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Brimonidine tartrate ophthalmic solution, 0.2%; Drug: Brinzolamide ophthalmic suspension, 1%; Other: Vehicle; Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961649

C-09-038

Details and patient eligibility

About

The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:

• its individual components (Brinz and Brim), and
• the concomitant administration of Brinz and Brim (Brinz+Brim).

Full description

This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign Informed Consent document.
• Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
• Any form of glaucoma other than open-angle glaucoma.
• Severe central vision loss in either eye.
• Chronic, recurrent, or severe inflammatory eye disease.
• Ocular trauma within the preceding 6 months.
• Ocular infection or ocular inflammation within the preceding 3 months.
• Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
• Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
• Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
• Ocular surgery within the preceding 6 months.
• Ocular laser surgery within the preceding 3 months.
• Any abnormality preventing reliable applanation tonometry.
• Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 4 patient groups

Brinz/Brim

Experimental group

Description:

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Treatment:

Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Other: Vehicle

Brinz

Active Comparator group

Description:

Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Treatment:

Other: Vehicle

Drug: Brinzolamide ophthalmic suspension, 1%

Brim

Active Comparator group

Description:

Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Treatment:

Other: Vehicle

Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Brinz+Brim

Active Comparator group

Description:

Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Treatment:

Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Drug: Brinzolamide ophthalmic suspension, 1%