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Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

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ClinicalTrials.gov Identifier: NCT00961649
Recruitment Status : Terminated
First Posted : August 19, 2009
Results First Posted : July 4, 2013
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Open-Angle Glaucoma
Ocular Hypertension
Interventions Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Drug: Brinzolamide ophthalmic suspension, 1%
Drug: Brimonidine tartrate ophthalmic solution, 0.2%
Other: Vehicle
Enrollment 195
Recruitment Details Subjects were recruited from 9 investigational centers in the United States.
Pre-assignment Details Of the 195 enrolled, 25 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (170).
Arm/Group Title Brinz/Brim Brinz+Brim Brinz Brim
Hide Arm/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 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 Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
Period Title: Overall Study
Started 41 44 44 41
Completed 32 40 39 37
Not Completed 9 4 5 4
Reason Not Completed
Adverse Event             4             0             0             2
Inadequate control of IOP             0             0             0             1
Patient has travel plans during holidays             0             0             1             0
Patient left to Mexico-family emergency             1             0             0             0
Study terminated by sponsor             4             4             4             1
Arm/Group Title Brinz/Brim Brinz+Brim Brinz Brim Total
Hide Arm/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 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 Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 41 44 44 41 170
Hide Baseline Analysis Population Description
This reporting group includes all randomized subjects, as treated.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 41 participants 170 participants
18 to 64 years 15 20 20 21 76
≥65 years 26 24 24 20 94
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 44 participants 44 participants 41 participants 170 participants
Female
23
  56.1%
22
  50.0%
26
  59.1%
25
  61.0%
96
  56.5%
Male
18
  43.9%
22
  50.0%
18
  40.9%
16
  39.0%
74
  43.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 44 participants 44 participants 41 participants 170 participants
41 44 44 41 170
1.Primary Outcome
Title 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
Hide Description 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).
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT: All subjects who received study drug and had at least 1 scheduled on-therapy study visit.
Arm/Group Title Brinz/Brim Brinz Brim
Hide Arm/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
Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
Overall Number of Participants Analyzed 41 44 41
Least Squares Mean (Standard Error)
Unit of Measure: millimeters mercury (mmHg)
Change from Baseline (BL) at 8 AM -5.5  (0.51) -5.7  (0.48) -4.1  (0.50)
Change from BL at +2 hours relative to 8 AM dosing -8.5  (0.51) -4.7  (0.48) -5.3  (0.51)
Change from BL at +7 hours relative to 8 AM dosing -5.4  (0.51) -2.8  (0.48) -3.0  (0.51)
Change from BL at +9 hours relative to 8 AM dosing -6.8  (0.51) -3.9  (0.48) -5.9  (0.51)
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
PP: All subjects who received study drug, satisfied inclusion/exclusion criteria, and had at least 1 scheduled on-therapy visit. Individual subject visits or data points were excluded if protocol criteria were violated at a subset of the subject's visits and the violations, in the opinion of the Medical Monitor, did not invalidate remaining visits.
Arm/Group Title Brinz/Brim Brinz+Brim
Hide Arm/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
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
Overall Number of Participants Analyzed 38 41
Least Squares Mean (Standard Error)
Unit of Measure: millimeters mercury (mmHg)
Change from Baseline (BL) at 8 AM -5.5  (0.52) -5.7  (0.50)
Change from BL at +2 hours relative to 8 AM dosing -8.4  (0.54) -8.3  (0.52)
Change from BL at +7 hours relative to 8 AM dosing -5.0  (0.54) -4.4  (0.52)
Change from BL at +9 hours relative to 8 AM dosing -6.3  (0.55) -6.3  (0.53)
Time Frame Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to the study medications.
Adverse Event Reporting Description An adverse event was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. All AEs were obtained as solicited comments from the study subjects and as observations by the Investigator as outlined in the study protocol.
 
Arm/Group Title Brinz/Brim Brinz+Brim Brinz Brim
Hide Arm/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 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 Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
All-Cause Mortality
Brinz/Brim Brinz+Brim Brinz Brim
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brinz/Brim Brinz+Brim Brinz Brim
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/41 (2.44%)   1/44 (2.27%)   0/44 (0.00%)   0/41 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1 [1]  1/41 (2.44%)  0/44 (0.00%)  0/44 (0.00%)  0/41 (0.00%) 
General disorders         
Chest pain  1 [1]  0/41 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/41 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1 [1]  1/41 (2.44%)  0/44 (0.00%)  0/44 (0.00%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1 [1]  0/41 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/41 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
Not related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brinz/Brim Brinz+Brim Brinz Brim
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/41 (24.39%)   8/44 (18.18%)   9/44 (20.45%)   7/41 (17.07%) 
Eye disorders         
Vision blurred  1  7/41 (17.07%)  6/44 (13.64%)  7/44 (15.91%)  6/41 (14.63%) 
Ocular hyperaemia  1  3/41 (7.32%)  0/44 (0.00%)  2/44 (4.55%)  1/41 (2.44%) 
Eye pain  1  0/41 (0.00%)  3/44 (6.82%)  2/44 (4.55%)  0/41 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matt Walker, PhD, Clinical Project Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00961649     History of Changes
Other Study ID Numbers: C-09-038
First Submitted: August 18, 2009
First Posted: August 19, 2009
Results First Submitted: May 17, 2013
Results First Posted: July 4, 2013
Last Update Posted: July 4, 2013