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Trial record 58 of 153 for:    Brimonidine

Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

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ClinicalTrials.gov Identifier: NCT01297920
Recruitment Status : Completed
First Posted : February 17, 2011
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%
Enrollment 1062
Recruitment Details Subjects were recruited and enrolled from 64 investigational centers in the United States.
Pre-assignment Details Of the 1062 enrolled, 372 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 (690), as treated.
Arm/Group Title Brinz/Brim Brinzolamide Brimonidine
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
Period Title: Overall Study
Started 221 234 235
Completed 163 207 178
Not Completed 58 27 57
Reason Not Completed
Adverse Event             42             10             38
Patient Decision Unrelated to AE             6             5             2
Noncompliance             1             0             0
Protocol Violation             1             3             0
Inadequate Control of IOP             7             9             17
Patient Did Not Meet Entrance Criteria             1             0             0
Arm/Group Title Brinz/Brim Brinzolamide Brimonidine Total
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months Total of all reporting groups
Overall Number of Baseline Participants 221 234 235 690
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 221 participants 234 participants 235 participants 690 participants
18 to 64 years 99 113 115 327
≥65 years 122 121 120 363
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 234 participants 235 participants 690 participants
Female
119
  53.8%
136
  58.1%
132
  56.2%
387
  56.1%
Male
102
  46.2%
98
  41.9%
103
  43.8%
303
  43.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 221 participants 234 participants 235 participants 690 participants
221 234 235 690
1.Primary Outcome
Title Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
Hide Description The study drug was instilled at 8 AM and 3 PM (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).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.
Arm/Group Title Brinz/Brim Brinzolamide Brimonidine
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
Overall Number of Participants Analyzed 196 216 203
Least Squares Mean (Standard Error)
Unit of Measure: millimeters mercury (mm HG)
8 AM (before study drug instillation) 21.1  (0.30) 22.0  (0.29) 23.2  (0.30)
+ 2 hours relative to 8 AM dosing 18.0  (0.30) 20.8  (0.29) 19.9  (0.30)
+ 7 hours relative to 8 AM dosing 19.5  (0.30) 20.7  (0.29) 21.5  (0.30)
+ 9 hours relative to 8 AM dosing 17.2  (0.30) 20.4  (0.29) 18.9  (0.30)
Time Frame Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study drug.
Adverse Event Reporting Description An adverse event was any untoward medical occurrence in a subject exposed to study drug. The AE did not necessarily have to have had a causal relationship with the study drug. Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
 
Arm/Group Title Brinz/Brim Brinzolamide Brimonidine
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
All-Cause Mortality
Brinz/Brim Brinzolamide Brimonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brinz/Brim Brinzolamide Brimonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/221 (3.17%)   7/234 (2.99%)   7/235 (2.98%) 
Cardiac disorders       
Atrial fibrillation  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Ear and labyrinth disorders       
Vertigo  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Eye disorders       
Retinal detachment  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Retinal tear  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
General disorders       
Chest pain  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Asthenia  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Hepatobiliary disorders       
Cholecystitis  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Immune system disorders       
Anaphylactic reaction  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Infections and infestations       
Abdominal abscess  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Appendicitis  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Bronchitis  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Pneumonia  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Otitis media chronic  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Injury, poisoning and procedural complications       
Injury  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic carcinoma  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Nervous system disorders       
Amnesia  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Psychiatric disorders       
Delirium  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Reproductive system and breast disorders       
Endometrial hyperplasia  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Benign prostatic hyperplasia  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Prostatitis  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
Surgical and medical procedures       
Aortic aneurysm repair  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Nephrectomy  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Prostatectomy  1  1/221 (0.45%)  0/234 (0.00%)  0/235 (0.00%) 
Intervertebral disc operation  1  0/221 (0.00%)  1/234 (0.43%)  0/235 (0.00%) 
Knee arthroplasty  1  0/221 (0.00%)  0/234 (0.00%)  1/235 (0.43%) 
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 Brinzolamide Brimonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/221 (23.98%)   35/234 (14.96%)   27/235 (11.49%) 
Eye disorders       
Conjunctivitis  1  16/221 (7.24%)  0/234 (0.00%)  15/235 (6.38%) 
Vision blurred  1  12/221 (5.43%)  18/234 (7.69%)  1/235 (0.43%) 
Eye allergy  1  14/221 (6.33%)  1/234 (0.43%)  5/235 (2.13%) 
Eye irritation  1  14/221 (6.33%)  6/234 (2.56%)  9/235 (3.83%) 
Nervous system disorders       
Dysgeusia  1  9/221 (4.07%)  24/234 (10.26%)  2/235 (0.85%) 
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: NCT01297920     History of Changes
Other Study ID Numbers: C-10-039
First Submitted: February 15, 2011
First Posted: February 17, 2011
Results First Submitted: May 17, 2013
Results First Posted: July 4, 2013
Last Update Posted: July 4, 2013