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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

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% fixed combination ophthalmic suspension
Drug: Vehicle
Drug: Brinzolamide 1% ophthalmic suspension
Drug: Brimonidine tartrate 0.2% ophthalmic solution
Enrollment 1184
Recruitment Details Subjects were recruited from 102 investigational centers in the Asia-Pacific region, Canada, Central and South America, Europe, and the United States.
Pre-assignment Details Of the 1184 enrolled, 294 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. Of the 890 randomized, 2 subjects did not receive study medication. This reporting group includes all randomized subjects who received study medication (888), as treated.
Arm/Group Title Brinz/Brim Brinz+Brim
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 452 436
Completed 385 361
Not Completed 67 75
Reason Not Completed
Adverse Event             48             58
Lost to Follow-up             2             2
Subject's decision unrelated to an AE             9             10
Inadequate control of IOP             4             4
Other             4             1
Arm/Group Title Brinz/Brim Brinz+Brim Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 452 436 888
Hide Baseline Analysis Population Description
This reporting group includes all subjects who received study medication, as treated.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 452 participants 436 participants 888 participants
<65 years 227 211 438
≥ 65 years 225 225 450
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 452 participants 436 participants 888 participants
Female
252
  55.8%
246
  56.4%
498
  56.1%
Male
200
  44.2%
190
  43.6%
390
  43.9%
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 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).
Time Frame Baseline (Day 1), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded.
Arm/Group Title Brinz/Brim Brinz+Brim
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 384 373
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
-8.5  (0.16) -8.3  (0.16)
Time Frame Adverse events (AE) were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject that was administered a study medication, regardless of causal relationship with the medication.
Adverse Event Reporting Description This reporting group includes all subjects who received study medication, as treated. 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 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. 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.
All-Cause Mortality
Brinz/Brim Brinz+Brim
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 (%)
Total   11/452 (2.43%)   8/436 (1.83%) 
Cardiac disorders     
Aortic valve incompetence  1  1/452 (0.22%)  0/436 (0.00%) 
Atrial fibrillation  1  0/452 (0.00%)  1/436 (0.23%) 
Myocardial infarction  1  0/452 (0.00%)  1/436 (0.23%) 
Ear and labyrinth disorders     
Vertigo  1  1/452 (0.22%)  0/436 (0.00%) 
Eye disorders     
Corneal erosion  1  2/452 (0.44%)  0/436 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/452 (0.00%)  1/436 (0.23%) 
Infections and infestations     
Kidney infection  1  1/452 (0.22%)  0/436 (0.00%) 
Pneumonia primary atypical  1  0/452 (0.00%)  1/436 (0.23%) 
Investigations     
Arthroscopy  1  1/452 (0.22%)  0/436 (0.00%) 
Prostatic specific antigen increased  1  1/452 (0.22%)  0/436 (0.00%) 
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis  1  1/452 (0.22%)  0/436 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Renal cell carcinoma  1  1/452 (0.22%)  0/436 (0.00%) 
Uterine cancer  1  0/452 (0.00%)  1/436 (0.23%) 
Nervous system disorders     
Headache  1  1/452 (0.22%)  0/436 (0.00%) 
Neuropathy peripheral  1  1/452 (0.22%)  0/436 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/452 (0.00%)  1/436 (0.23%) 
Sleep apnoea syndrome  1  0/452 (0.00%)  1/436 (0.23%) 
Surgical and medical procedures     
Finger amputation  1  1/452 (0.22%)  0/436 (0.00%) 
Mastectomy  1  1/452 (0.22%)  0/436 (0.00%) 
Vascular disorders     
Venous occlusion  1  0/452 (0.00%)  1/436 (0.23%) 
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 (%)
Total   0/452 (0.00%)   0/436 (0.00%) 
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: NCT01309204     History of Changes
Other Study ID Numbers: C-10-041
2010-024513-31 ( EudraCT Number )
First Submitted: March 3, 2011
First Posted: March 7, 2011
Results First Submitted: January 24, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014