Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00961649
• Other study ID #: C-09-038
• Status: Terminated
• Phase: Phase 2
• First received: August 18, 2009
• Last updated: May 17, 2013
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 195
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

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

• Brinzolamide ophthalmic suspension, 1%

• Brimonidine tartrate ophthalmic solution, 0.2%

Other:
• Vehicle
Inactive ingredients used as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).	Baseline, Week 6	No
Primary	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	The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.	Baseline, Week 6	No