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Trial record 45 of 154 for:    Brimonidine

Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

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ClinicalTrials.gov Identifier: NCT01297517
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : May 13, 2013
Last Update Posted : May 21, 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 1001
Recruitment Details Subjects were recruited from 68 study centers in the US.
Pre-assignment Details Of the 1001 enrolled, 341 subjects did not qualify for treatment and were exited without exposure to product. The 660 subjects eligible for treatment were randomized (1:1:1) to study drug. This reporting group includes all randomized subjects, as treated.
Arm/Group Title Brinzolamide/Brimonidine Brinzolamide Brimonidine
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Period Title: Overall Study
Started 214 226 220
Completed 187 214 193
Not Completed 27 12 27
Reason Not Completed
Adverse Event             21             7             16
Lost to Follow-up             1             0             1
Patient Decision Unrelated to AE             2             3             7
Noncompliance             1             0             0
Protocol Violation             1             1             1
Inadequate Control of IOP             1             1             2
Arm/Group Title Brinzolamide/Brimonidine Brinzolamide Brimonidine Total
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Total of all reporting groups
Overall Number of Baseline Participants 214 226 220 660
Hide Baseline Analysis Population Description
This reporting group includes all participants randomized to study drug, as treated.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 226 participants 220 participants 660 participants
18 to 64 years 107 101 117 325
≥65 years 107 125 103 335
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 226 participants 220 participants 660 participants
Female
140
  65.4%
128
  56.6%
135
  61.4%
403
  61.1%
Male
74
  34.6%
98
  43.4%
85
  38.6%
257
  38.9%
1.Primary Outcome
Title Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
Hide Description At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. 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 patients 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 Brinzolamide/Brimonidine Brinzolamide Brimonidine
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Overall Number of Participants Analyzed 189 213 192
Least Squares Mean (Standard Error)
Unit of Measure: millimeters mercury (mm Hg)
8 am (before study drug instillation) 20.5  (0.29) 21.6  (0.28) 23.3  (0.29)
+2 hrs relative to 8 am dosing 17.2  (0.29) 20.4  (0.28) 19.7  (0.29)
+7 hrs relative to 8 am dosing 18.7  (0.29) 20.4  (0.28) 21.3  (0.29)
+9 hrs relative to 8 am dosing 17.0  (0.29) 20.0  (0.28) 18.8  (0.29)
Time Frame Adverse events were collected for the duration of the study (1 year). An AE was any untoward medical occurrence in a patient administered a study medication, regardless of whether or not the event had a causal relationship with the medication.
Adverse Event Reporting Description This reporting group includes all participants randomized to study drug, as treated. Adverse events were obtained as solicited comments from the study patients and as observations by the study investigator as outlined in the study protocol.
 
Arm/Group Title Brinzolamide/Brimonidine Brinzolamide Brimonidine
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
All-Cause Mortality
Brinzolamide/Brimonidine Brinzolamide Brimonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brinzolamide/Brimonidine Brinzolamide Brimonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/214 (0.93%)   6/226 (2.65%)   2/220 (0.91%) 
Blood and lymphatic system disorders       
Anaemia  1 [1]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Cardiac disorders       
Angina pectoris  1 [1]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1 [1]  1/214 (0.47%)  0/226 (0.00%)  0/220 (0.00%) 
General disorders       
Chest pain  1 [2]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Chest pain  1 [1]  0/214 (0.00%)  0/226 (0.00%)  2/220 (0.91%) 
Injury, poisoning and procedural complications       
Collapse of lung  1 [1]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Injury  1 [1]  0/214 (0.00%)  0/226 (0.00%)  1/220 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Vulval neoplasm  1 [1]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Nervous system disorders       
Amnesia  1 [1]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Surgical and medical procedures       
Cardiac pacemaker insertion  1 [1]  1/214 (0.47%)  0/226 (0.00%)  0/220 (0.00%) 
Vertebroplasty  1 [1]  0/214 (0.00%)  1/226 (0.44%)  0/220 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
[1]
Not related
[2]
Related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brinzolamide/Brimonidine Brinzolamide Brimonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/214 (9.35%)   26/226 (11.50%)   1/220 (0.45%) 
Eye disorders       
Vision blurred  1  14/214 (6.54%)  15/226 (6.64%)  1/220 (0.45%) 
Nervous system disorders       
Dysgeusia  1  8/214 (3.74%)  14/226 (6.19%)  0/220 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring 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: NCT01297517     History of Changes
Other Study ID Numbers: C-10-033
First Submitted: February 15, 2011
First Posted: February 16, 2011
Results First Submitted: March 27, 2013
Results First Posted: May 13, 2013
Last Update Posted: May 21, 2013