Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension

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

Phase: Phase 2

Status: Terminated

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
James Teague, BS, Sr. Clinical Manager, Study Director, Affiliation: Alcon Research

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).

Official title: Safety and IOP-Lowering Efficacy of Brinzolamide/Brimonidine Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma and/or Ocular Hypertension

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim

Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim

Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: October 2009
Last updated: May 17, 2013