Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

• ClinicalTrials.gov Identifier: NCT01297517
• Recruitment Status: Completed
• First Posted: February 16, 2011
• Results First Posted: May 13, 2013
• Last Update Posted: May 21, 2013
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: February 15, 2011
• First Posted Date: February 16, 2011
• Results First Submitted Date: March 27, 2013
• Results First Posted Date: May 13, 2013
• Last Update Posted Date: May 21, 2013
• Study Start Date: February 2011
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2013)

Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h) [ Time Frame: Month 3 ]

At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. 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).

• Original Primary Outcome Measures (submitted: February 15, 2011): Efficacy: mean Intraocular Pressure (IOP) [ Time Frame: 3 months ]
• Change History: Complete list of historical versions of study NCT01297517 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
• Official Title: Three Month Efficacy and Safety Study of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
• Brief Summary: The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.
• Detailed Description: This study consisted of 6 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 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Open-Angle Glaucoma
• Ocular Hypertension

Intervention

• Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
• Drug: Brinzolamide ophthalmic suspension, 1%
  Other Name: AZOPT®
• Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Study Arms

• Experimental: Brinzolamide/Brimonidine
  Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
  Intervention: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
• Active Comparator: Brinzolamide
  Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
  Intervention: Drug: Brinzolamide ophthalmic suspension, 1%
• Active Comparator: Brimonidine
  Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
  Intervention: Drug: Brimonidine tartrate ophthalmic solution, 0.2%

• Publications *: Katz G, Dubiner H, Samples J, Vold S, Sall K. Three-month randomized trial of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%. JAMA Ophthalmol. 2013 Jun;131(6):724-30. doi: 10.1001/jamaophthalmol.2013.188.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 27, 2013): 1001
• Original Estimated Enrollment (submitted: February 15, 2011): 750
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01297517
• Other Study ID Numbers: C-10-033
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alcon Research
• Study Sponsor: Alcon Research
• Collaborators: Not Provided

Investigators

• Study Director: James Teague, BS, Sr. Clinical Manager; Alcon Research

• PRS Account: Alcon Research
• Verification Date: May 2013