Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®

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: NCT01937299
Recruitment Status : Completed
First Posted : September 9, 2013
Results First Posted : May 14, 2015
Last Update Posted : May 14, 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: Travoprost 0.004% ophthalmic solution
Enrollment 307
Recruitment Details Participants were recruited from 32 investigational centers located in the US.
Pre-assignment Details Of the 307 enrolled, 74 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (233).
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 travoprost 0.004% ophthalmic solution, 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 travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Period Title: Overall Study
Started 117 116
Completed 103 112
Not Completed 14 4
Reason Not Completed
Adverse Event             13             0
Lack of Efficacy             0             4
Withdrawal by Subject             1             0
Arm/Group Title SIMBRINZA Vehicle Total
Hide Arm/Group Description 1 drop instilled 3 times a day in each eye for 6 weeks as adjunctive therapy to travoprost ophthalmic solution 0.004% 1 drop instilled 3 times a day in each eye for 6 weeks in conjunction with travoprost ophthalmic solution 0.004% Total of all reporting groups
Overall Number of Baseline Participants 113 116 229
Hide Baseline Analysis Population Description
This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit (intent-to-treat).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 116 participants 229 participants
67.5  (10.3) 66.0  (10.6) 66.8  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 116 participants 229 participants
Female
69
  61.1%
67
  57.8%
136
  59.4%
Male
44
  38.9%
49
  42.2%
93
  40.6%
Mean Diurnal Intraocular Pressure (IOP) at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 113 participants 116 participants 229 participants
22.48  (2.507) 22.66  (2.407) 22.57  (2.453)
[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 analyses. 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 study visit. 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 travoprost 0.004% ophthalmic solution, 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 travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 103 112
Mean (Standard Deviation)
Unit of Measure: mmHg
17.44  (2.838) 20.34  (3.702)
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 analyses. 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 study visit. 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 travoprost 0.004% ophthalmic solution, 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 travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 103 112
Mean (Standard Deviation)
Unit of Measure: mmHg
-5.10  (2.637) -2.22  (2.925)
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 analyses. 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 study visit. 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 travoprost 0.004% ophthalmic solution, 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 travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Overall Number of Participants Analyzed 103 112
Mean (Standard Deviation)
Unit of Measure: percent change
-22.27  (10.842) -9.57  (12.923)
Time Frame Adverse events (AEs) were collected for the duration of the study, Oct 2013-Apr 2014. This analysis population includes all consented subjects. Adverse events are reported as pre-treatment and treatment-emergent.
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 Travoprost 0.004% ophthalmic solution, 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 travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
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   1/307 (0.33%)   0/117 (0.00%)   0/116 (0.00%) 
Nervous system disorders       
Syncope  1  1/307 (0.33%)  0/117 (0.00%)  0/116 (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   3/307 (0.98%)   26/117 (22.22%)   12/116 (10.34%) 
Eye disorders       
Conjunctival hyperaemia  1  2/307 (0.65%)  16/117 (13.68%)  7/116 (6.03%) 
Vision blurred  1  0/307 (0.00%)  7/117 (5.98%)  5/116 (4.31%) 
Gastrointestinal disorders       
Dry mouth  1  1/307 (0.33%)  9/117 (7.69%)  2/116 (1.72%) 
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: Doug Hubatsch, Global Brand Leader, Medical Affairs, Glaucoma
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01937299     History of Changes
Other Study ID Numbers: M-13-019
First Submitted: September 4, 2013
First Posted: September 9, 2013
Results First Submitted: April 29, 2015
Results First Posted: May 14, 2015
Last Update Posted: May 14, 2015