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Efficacy and Safety of Brinzolamide/Brimonidine Fixed Combination BID Compared to Brinzolamide BID Plus Brimonidine BID in Subjects With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

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ClinicalTrials.gov Identifier: NCT02339584
Recruitment Status : Completed
First Posted : January 15, 2015
Results First Posted : September 7, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Open-Angle Glaucoma
Ocular Hypertension
Interventions Drug: Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension
Drug: Brinzolamide 10 mg/mL eye drops, suspension
Drug: Brimonidine 2 mg/mL eye drops, solution
Drug: Vehicle
Enrollment 493
Recruitment Details Subjects were recruited from 26 study centers located in China (14), Russia (9), and Taiwan (3).
Pre-assignment Details Of the 493 enrolled, 64 subjects were exited as screen failures and another 50 discontinued prior to randomization. This reporting group includes all randomized subjects (379).
Arm/Group Title Brinz/Brim Brinz+Brim
Hide Arm/Group Description Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
Period Title: Overall Study
Started 188 191
Completed 173 176
Not Completed 15 15
Reason Not Completed
Adverse Event             11             7
Lack of Efficacy             0             1
Physician Decision             1             2
Protocol Violation             1             1
Withdrawal by Subject             2             4
Arm/Group Title Brinz/Brim Brinz+Brim Total
Hide Arm/Group Description Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months Total of all reporting groups
Overall Number of Baseline Participants 172 177 349
Hide Baseline Analysis Population Description
This analysis population includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria, and had at least 1 scheduled on-therapy study visit (Per Protocol (PP) Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 177 participants 349 participants
52.3  (16.29) 52.6  (16.25) 52.4  (16.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 177 participants 349 participants
Female
97
  56.4%
98
  55.4%
195
  55.9%
Male
75
  43.6%
79
  44.6%
154
  44.1%
Mean Diurnal Intraocular Pressure (IOP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 172 participants 177 participants 349 participants
24.62  (2.661) 24.59  (2.660) 24.61  (2.657)
[1]
Measure Description: IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. Only one eye (study eye) contributed to the analysis.
1.Primary Outcome
Title Mean Diurnal IOP Change From Baseline at Month 3
Hide Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.
Time Frame Baseline (Day 0), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis Set. Missing Month 3 data were imputed using a last observation carried forward method (LOCF).
Arm/Group Title Brinz/Brim Brinz+Brim
Hide Arm/Group Description:
Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
Overall Number of Participants Analyzed 169 171
Mean (Standard Error)
Unit of Measure: mmHg
-7.2  (0.34) -7.3  (0.34)
Time Frame Adverse events (AEs) were collected from time of consent for the duration of a subject’s participation in the study (up to 134 days).
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject who is administered study treatment regardless of whether the event has a causal relationship with the treatment. This analysis includes all subjects who received at least 1 dose of study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the protocol. Ocular AEs are presented for both study eye and non-study eye combined.
 
Arm/Group Title Brinz/Brim Brinz+Brim
Hide Arm/Group Description All subjects exposed to Brinz/Brim All subjects exposed to Brinz+Brim
All-Cause Mortality
Brinz/Brim Brinz+Brim
Affected / at Risk (%) Affected / at Risk (%)
Total   0/188 (0.00%)   0/191 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brinz/Brim Brinz+Brim
Affected / at Risk (%) Affected / at Risk (%)
Total   4/188 (2.13%)   4/191 (2.09%) 
Ear and labyrinth disorders     
Deafness neurosensory  1  1/188 (0.53%)  0/191 (0.00%) 
Gastrointestinal disorders     
Gastritis  1  0/188 (0.00%)  1/191 (0.52%) 
Pancreatitis acute  1  1/188 (0.53%)  0/191 (0.00%) 
Injury, poisoning and procedural complications     
Ligament injury  1  1/188 (0.53%)  0/191 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  0/188 (0.00%)  1/191 (0.52%) 
Nervous system disorders     
Diabetic neuropathy  1  0/188 (0.00%)  1/191 (0.52%) 
Renal and urinary disorders     
Renal colic  1  1/188 (0.53%)  0/191 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Vocal cord leukoplakia  1  0/188 (0.00%)  1/191 (0.52%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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   12/188 (6.38%)   13/191 (6.81%) 
Eye disorders     
Conjunctival hyperaemia  1  12/188 (6.38%)  13/191 (6.81%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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: Clinical Scientific Associate Director, GCRA, GDD
Organization: Enter Alcon, A Novartis Division
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02339584     History of Changes
Other Study ID Numbers: C-13-013
First Submitted: January 13, 2015
First Posted: January 15, 2015
Results First Submitted: August 7, 2017
Results First Posted: September 7, 2017
Last Update Posted: July 2, 2018