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Trial record 84 of 152 for:    Brimonidine

Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

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ClinicalTrials.gov Identifier: NCT01937312
Recruitment Status : Completed
First Posted : September 9, 2013
Results First Posted : June 8, 2015
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Ocular Hypertension
Open Angle Glaucoma
Interventions Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Drug: Vehicle
Drug: Prostaglandin analogue
Enrollment 282
Recruitment Details Participants were recruited and enrolled from 30 investigative sites located in the US.
Pre-assignment Details Of the 282 enrolled, 93 participants were exited from the study as screen failures prior to randomization. This reporting group includes all randomized participants (189). Note: One subject randomized to SIMBRINZA® Suspension was not exposed to investigational product.
Arm/Group Title SIMBRINZA Vehicle
Hide Arm/Group Description 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Period Title: Overall Study
Started 94 95
Treated 93 95
Completed 83 92
Not Completed 11 3
Reason Not Completed
Adverse Event             10             1
Lack of Efficacy             0             1
Withdrawal of subject prior to treatment             1             1
Arm/Group Title SIMBRINZA Vehicle Total
Hide Arm/Group Description 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 88 94 182
Hide Baseline Analysis Population Description
This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 94 participants 182 participants
65.5  (9.4) 64.7  (9.6) 65.1  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 94 participants 182 participants
Female
53
  60.2%
63
  67.0%
116
  63.7%
Male
35
  39.8%
31
  33.0%
66
  36.3%
Mean Diurnal Intraocular Pressure (IOP) at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 88 participants 94 participants 182 participants
22.68  (2.123) 22.39  (2.774) 22.53  (2.478)
[1]
Measure Description: Diurnal IOP at Baseline was defined as the average of the four Baseline IOP measurements at timepoints 8 AM, 10 AM, 3 PM, and 5 PM. For each timepoint, the baseline IOP was defined as the average of the timepoint-matched IOP measurements at the Eligibility 1 and Eligibility 2 Visits.
1.Primary Outcome
Title Mean Diurnal Intraocular Pressure (IOP) at Week 6
Hide Description Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.
Arm/Group Title SIMBRINZA Vehicle
Hide Arm/Group Description:
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 83 92
Mean (Standard Deviation)
Unit of Measure: mmHg
17.01  (2.897) 20.37  (3.914)
2.Secondary Outcome
Title Mean Diurnal IOP Change From Baseline to Week 6
Hide Description Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.
Arm/Group Title SIMBRINZA Vehicle
Hide Arm/Group Description:
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 83 92
Mean (Standard Deviation)
Unit of Measure: mmHg
-5.69  (2.571) -1.99  (2.865)
3.Secondary Outcome
Title Mean Diurnal IOP Percentage Change From Baseline to Week 6
Hide Description Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.
Arm/Group Title SIMBRINZA Vehicle
Hide Arm/Group Description:
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 83 92
Mean (Standard Deviation)
Unit of Measure: percent change
-24.88  (10.818) -8.50  (12.396)
4.Secondary Outcome
Title Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)
Hide Description IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.
Arm/Group Title SIMBRINZA Vehicle
Hide Arm/Group Description:
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 83 92
Mean (Standard Deviation)
Unit of Measure: mmHg
8 AM 19.4  (3.53) 21.4  (4.33)
10 AM 15.8  (3.54) 20.2  (4.17)
3 PM 17.2  (3.15) 19.9  (4.28)
5 PM 15.6  (3.14) 19.9  (4.41)
Time Frame Adverse events (AEs) were collected for the duration of the study, Oct 2013-May 2014. Adverse events are reported as pre-treatment and treatment-emergent. The treatment-emergent analysis set included all subjects exposed to investigational product.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. All AEs were obtained as solicited and spontaneous comments from the subjects, and as observations by the Investigator, as outlined in the study protocol.
 
Arm/Group Title Pre-Treatment SIMBRINZA Vehicle
Hide Arm/Group Description Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
All-Cause Mortality
Pre-Treatment SIMBRINZA Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pre-Treatment SIMBRINZA Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/282 (0.00%)   1/93 (1.08%)   0/95 (0.00%) 
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/282 (0.00%)  1/93 (1.08%)  0/95 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastatic malignant melanoma  1  0/282 (0.00%)  1/93 (1.08%)  0/95 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-Treatment SIMBRINZA Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/282 (0.71%)   16/93 (17.20%)   8/95 (8.42%) 
Eye disorders       
Vision Blurred  1  0/282 (0.00%)  9/93 (9.68%)  6/95 (6.32%) 
Eye irritation  1  1/282 (0.35%)  6/93 (6.45%)  1/95 (1.05%) 
Eye Pruritus  1  0/282 (0.00%)  6/93 (6.45%)  0/95 (0.00%) 
Ocular hyperaemia  1  2/282 (0.71%)  5/93 (5.38%)  2/95 (2.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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: Global Brand Leader, Medical Affairs, Glaucoma
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01937312     History of Changes
Other Study ID Numbers: M-13-020
First Submitted: September 4, 2013
First Posted: September 9, 2013
Results First Submitted: May 22, 2015
Results First Posted: June 8, 2015
Last Update Posted: July 28, 2015