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Trial record 56 of 152 for:    Brimonidine

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

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ClinicalTrials.gov Identifier: NCT01310777
Recruitment Status : Completed
First Posted : March 9, 2011
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Open-Angle Glaucoma
Ocular Hypertension
Interventions Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Drug: Brinzolamide 1% ophthalmic suspension
Drug: Brimonidine tartrate 0.2% ophthalmic solution
Enrollment 771
Recruitment Details Subjects were recruited from 63 investigational centers in the Asia-Pacific region, the European Union, Latin America and Caribbean nations, and the United States.
Pre-assignment Details Of the 771 enrolled, 211 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 (560).
Arm/Group Title Brinz/Brim Brinz Brim
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Period Title: Overall Study
Started 193 192 175
Completed 160 178 145
Not Completed 33 14 30
Reason Not Completed
Adverse Event             23             1             15
Lost to Follow-up             0             4             1
Patient's Decision Unrelated to AE             1             1             2
Inadequate Control of IOP             5             7             10
Other             4             1             2
Arm/Group Title Brinz/Brim Brinz Brim Total
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months Total of all reporting groups
Overall Number of Baseline Participants 193 192 175 560
Hide Baseline Analysis Population Description
This reporting group includes all randomized subjects.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 193 participants 192 participants 175 participants 560 participants
<65 years 91 87 79 257
≥65 years 102 105 96 303
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 192 participants 175 participants 560 participants
Female
106
  54.9%
102
  53.1%
102
  58.3%
310
  55.4%
Male
87
  45.1%
90
  46.9%
73
  41.7%
250
  44.6%
1.Primary Outcome
Title Mean Diurnal IOP Change From Baseline at Month 3
Hide Description Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 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).
Time Frame Baseline (Day 1), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) analysis set included all subjects who received study drug and completed 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, 1 drop instilled in each eye 2 times a day for 6 months
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Overall Number of Participants Analyzed 176 182 161
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
-7.9  (0.22) -6.5  (0.23) -6.4  (0.24)
Time Frame Adverse events were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of causal relationship with the medication.
Adverse Event Reporting Description This reporting group includes all subjects exposed to study drug. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
 
Arm/Group Title Brinz/Brim Brinz Brim
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
All-Cause Mortality
Brinz/Brim Brinz Brim
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brinz/Brim Brinz Brim
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/193 (2.59%)   2/192 (1.04%)   3/175 (1.71%) 
Eye disorders       
Macular degeneration  1  0/193 (0.00%)  0/192 (0.00%)  1/175 (0.57%) 
Hepatobiliary disorders       
Cholelithiasis  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Cholecystitis  1  0/193 (0.00%)  1/192 (0.52%)  0/175 (0.00%) 
Infections and infestations       
Cellulitis  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Cystitis  1  0/193 (0.00%)  0/192 (0.00%)  1/175 (0.57%) 
Injury, poisoning and procedural complications       
Vascular pseudoaneurysm  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Concussion  1  0/193 (0.00%)  0/192 (0.00%)  1/175 (0.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Cervix carcinoma  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Pancreatic carcinoma  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Renal cell carcinoma  1  1/193 (0.52%)  0/192 (0.00%)  0/175 (0.00%) 
Nervous system disorders       
Carotid artery occlusion  1  0/193 (0.00%)  0/192 (0.00%)  1/175 (0.57%) 
Headache  1  0/193 (0.00%)  0/192 (0.00%)  1/175 (0.57%) 
Renal and urinary disorders       
Calculus urethral  1  0/193 (0.00%)  1/192 (0.52%)  0/175 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/193 (22.80%)   12/192 (6.25%)   18/175 (10.29%) 
Eye disorders       
Ocular hyperaemia  1  11/193 (5.70%)  3/192 (1.56%)  9/175 (5.14%) 
Conjunctivitis  1  11/193 (5.70%)  2/192 (1.04%)  2/175 (1.14%) 
Vision Blurred  1  11/193 (5.70%)  1/192 (0.52%)  3/175 (1.71%) 
Eye Pain  1  11/193 (5.70%)  3/192 (1.56%)  0/175 (0.00%) 
Gastrointestinal disorders       
Dry Mouth  1  7/193 (3.63%)  2/192 (1.04%)  9/175 (5.14%) 
Nervous system disorders       
Dysgeusia  1  11/193 (5.70%)  4/192 (2.08%)  2/175 (1.14%) 
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
Name/Title: Matt Walker, PhD, Clinical Project Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01310777     History of Changes
Other Study ID Numbers: C-10-040
2010-024512-34 ( EudraCT Number )
First Submitted: March 7, 2011
First Posted: March 9, 2011
Results First Submitted: January 24, 2014
Results First Posted: March 6, 2014
Last Update Posted: March 6, 2014