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A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01426867
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : July 8, 2013
Last Update Posted : July 8, 2013
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 ophthalmic suspension, 1%
Drug: Brimonidine tartrate ophthalmic solution, 0.2%
Enrollment 103
Recruitment Details Subjects were recruited from 5 investigational centers in the United States.
Pre-assignment Details Of the 103 enrolled, 2 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 (101).
Arm/Group Title Brinz/Brim Brinzolamide Brimonidine
Hide Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Period Title: Overall Study
Started 33 34 34
Completed 33 34 34
Not Completed 0 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 affected eye 3 times a day for 7 days Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days Total of all reporting groups
Overall Number of Baseline Participants 33 34 34 101
Hide Baseline Analysis Population Description
This reporting group includes all randomized subjects.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 34 participants 101 participants
18 to 64 years 8 12 11 31
≥65 years 25 22 23 70
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 34 participants 34 participants 101 participants
Female
20
  60.6%
23
  67.6%
23
  67.6%
66
  65.3%
Male
13
  39.4%
11
  32.4%
11
  32.4%
35
  34.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 34 participants 34 participants 101 participants
33 34 34 101
1.Primary Outcome
Title Mean Ocular Discomfort Score
Hide Description Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.
Arm/Group Title Brinz/Brim Brinzolamide Brimonidine
Hide Arm/Group Description:
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Overall Number of Participants Analyzed 33 34 34
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.8  (0.9) 0.4  (0.6) 0.3  (0.5)
Time Frame Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study medication.
Adverse Event Reporting Description An adverse event was defined as any untoward medical occurrence in a subject administered a study medication, regardless of whether or not the event had a causal relationship with the medication. Adverse events were obtained as solicited comments from the subjects and as 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 affected eye 3 times a day for 7 days Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
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   0/33 (0.00%)   0/34 (0.00%)   0/34 (0.00%) 
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   5/33 (15.15%)   7/34 (20.59%)   0/34 (0.00%) 
Eye disorders       
Vision blurred  1  2/33 (6.06%)  4/34 (11.76%)  0/34 (0.00%) 
Eye irritation  1  2/33 (6.06%)  3/34 (8.82%)  0/34 (0.00%) 
Nervous system disorders       
Dysgeusia  1  2/33 (6.06%)  1/34 (2.94%)  0/34 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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: NCT01426867     History of Changes
Other Study ID Numbers: C-11-002
First Submitted: August 24, 2011
First Posted: September 1, 2011
Results First Submitted: May 17, 2013
Results First Posted: July 8, 2013
Last Update Posted: July 8, 2013