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Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01309204
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE March 3, 2011
First Posted Date  ICMJE March 7, 2011
Results First Submitted Date  ICMJE January 24, 2014
Results First Posted Date  ICMJE April 7, 2014
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
Mean Diurnal IOP Change From Baseline at Month 3 [ Time Frame: Baseline (Day 1), Month 3 ]
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject 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  ICMJE
 (submitted: March 3, 2011)
Efficacy: mean diurnal IOP (average over time points) change from baseline [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT01309204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Brief Summary The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.
Detailed Description This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension
  • Drug: Vehicle
    Inactive ingredients used as a placebo for masking purposes
  • Drug: Brinzolamide 1% ophthalmic suspension
    Other Name: AZOPT™
  • Drug: Brimonidine tartrate 0.2% ophthalmic solution
Study Arms  ICMJE
  • Experimental: Brinz/Brim
    Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
    Interventions:
    • Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension
    • Drug: Vehicle
  • Active Comparator: Brinz+Brim
    Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
    Interventions:
    • Drug: Brinzolamide 1% ophthalmic suspension
    • Drug: Brimonidine tartrate 0.2% ophthalmic solution
Publications * Gandolfi SA, Lim J, Sanseau AC, Parra Restrepo JC, Hamacher T. Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension. Adv Ther. 2014 Dec;31(12):1213-27. doi: 10.1007/s12325-014-0168-y. Epub 2014 Nov 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2013)
1184
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2011)
820
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
  • Meet qualifying IOP entry criteria.
  • Able to understand and sign an informed consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Severe central visual field loss.
  • Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
  • Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
  • Chronic, recurrent or severe inflammatory eye disease.
  • Ocular trauma within the preceding 6 months.
  • Ocular infection or inflammation within the preceding 3 months.
  • Clinically significant or progressive retinal disease.
  • Other ocular pathology.
  • Intraocular surgery within the 6 months prior to entry.
  • Ocular laser surgery within the 3 months prior to entry.
  • Any abnormality preventing reliable applanation tonometry.
  • Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
  • Recent use of high-dose (>1 gram daily) salicylate therapy.
  • Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01309204
Other Study ID Numbers  ICMJE C-10-041
2010-024513-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steve Burmaster, PhD Alcon Research
PRS Account Alcon Research
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP