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Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

Sponsor
Alcon Research (Industry)
Overall Status
Terminated
CT.gov ID
NCT02730871
Collaborator
(none)
173
Enrollment
1
Location
2
Arms
24.6
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.

Condition or Disease Intervention/Treatment Phase
  • Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
  • Drug: Brinzolamide/brimonidine vehicle
  • Drug: Travoprost 0.004%/timolol 0.5% solution
 Phase 4

Detailed Description

This study is divided into 2 sequential phases for a total of 5 visits. Phase I of the study is the open-labeled Screening/Eligibility Phase, which includes a Screening Visit followed by 2 Eligibility Visits. Phase II of the study is the randomized, double-masked Treatment Phase, which includes 2 on-therapy visits: Visit 4 (at Week 2) and Visit 5 (Week 6, Exit Visit).

Study Design

Study Type:
Interventional
Actual Enrollment :
173 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)
Actual Study Start Date :
Jun 24, 2016
Actual Primary Completion Date :
Jul 13, 2018
Actual Study Completion Date :
Jul 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Simbrinza + Duotrav

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Other Names:
  • SIMBRINZA® suspension

    • Drug: Travoprost 0.004%/timolol 0.5% solution
    1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase
    Other Names:
  • DUOTRAV®

    		•
    Placebo Comparator: Vehicle + Duotrav

    Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)

    Drug: Brinzolamide/brimonidine vehicle
    Inactive ingredients used as placebo comparator

    Drug: Travoprost 0.004%/timolol 0.5% solution
    1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase
    Other Names:
  • DUOTRAV®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6 [Baseline, Week 6]

      IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.

    Secondary Outcome Measures

    1. Mean Diurnal IOP at Week 6 [Week 6]

      IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was used for the analyses.

    2. Mean Percentage Change From Baseline in Diurnal IOP at Week 6 [Baseline, Week 6]

      IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.

    3. Mean Change From Baseline in IOP (09:00, 11:00) at Week 6 [Baseline, Week 6]

      IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.

    4. Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6 [Baseline, Week 6]

      IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of open-angle glaucoma (including pseudoexfoliation or pigment dispersion glaucoma) or ocular hypertension.

    • Currently on treatment with Travoprost 0.004%/Timolol 0.5% prescribed as approved in the country, on morning or evening dosing for at least 28 days prior to screening, and in the opinion of the Investigator may benefit from further IOP lowering.

    • Mean IOP measurements at both the Eligibility 1 and Eligibility 2 visits, in at least 1 eye (the same eye(s) ≥ 19 and ≤ 28 mmHg at 09:00 while on a Travoprost 0.004%/ Timolol 0.5% solution.

    • Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee.

    • Willing and able to attend all study visits.

    Exclusion Criteria:

    • Women of childbearing potential: not postmenopausal for at least 1 year or less than 6 weeks since sterilization, currently pregnant; have a positive result on the urine pregnancy test at Screening; intend to become pregnant during the study period; breast-feeding; or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.

    • Mean IOP > 28 mmHg at any time point in either eye during the Screening/Eligibility Phase.

    • Any form of glaucoma other than open-angle glaucoma or ocular hypertension.

    • Severe central visual field loss in either eye.

    • Chronic, recurrent or severe inflammatory eye disease in either eye.

    • Ocular trauma in either eye within the past 6 months prior to the Screening visit.

    • Ocular infection or ocular inflammation in either eye within the past 3 months prior to the Screening visit.

    • Retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.

    • Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal) in either eye.

    • Other ocular pathology (including severe dry eye) in either eye that may, in the opinion of the Investigator, preclude the safe administration of any study medication.

    • Intraocular surgery in either eye within the past 6 months prior to the Screening visit.

    • Ocular laser surgery in either eye within the past 3 months prior to the Screening visit.

    • Any other condition including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study.

    • Asthma, history of asthma, or severe chronic obstructive pulmonary disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Contact Alcon for Locations (Europe, Asia, and Latin America) Fort Worth Texas United States 76134

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Assoc Global Trial Director, TM Ophtha, Alcon Research

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02730871
    Other Study ID Numbers:
    • GLJ576-P001
    • 2016-000176-20
    First Posted:
    Apr 7, 2016
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle
    Ocular Hypertension
    Timolol
    Brimonidine Tartrate
    Travoprost
    Brinzolamide

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from sites located in Argentina, Australia, Belgium, Chile, Columbia, Germany, Greece, Italy, Malaysia, Poland, Spain, Taiwan, and the United Kingdom.
    Pre-assignment Detail Of the 173 enrolled, 39 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Period Title: Overall Study
    STARTED 67 67
    Full Analysis Set (FAS) 67 67
    Safety Analysis Set 67 67
    COMPLETED 61 67
    NOT COMPLETED 6 0

    Baseline Characteristics

    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav Total
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Total of all reporting groups
    Overall Participants 67 67 134
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.7
    (13.47)
    65.7
    (11.77)
    65.7
    (12.60)
    Sex: Female, Male (Count of Participants)
    Female
    32
    47.8%
    41
    61.2%
    73
    54.5%
    Male
    35
    52.2%
    26
    38.8%
    61
    45.5%
    Race/Ethnicity, Customized (Count of Participants)
    White
    50
    74.6%
    57
    85.1%
    107
    79.9%
    Black or African American
    2
    3%
    0
    0%
    2
    1.5%
    Asian
    6
    9%
    7
    10.4%
    13
    9.7%
    Other
    9
    13.4%
    3
    4.5%
    12
    9%
    Intraocular Pressure (IOP) (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    21.6
    (1.78)
    21.8
    (1.90)
    21.7
    (1.84)

    Outcome Measures

    1. Primary Outcome
    Title Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6
    Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
    Time Frame Baseline, Week 6

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Measure Participants 61 67
    Mean (Standard Deviation) [mmHg]
    -4.5
    (2.69)
    -2.4
    (3.01)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.15
    Confidence Interval (2-Sided) 95%
    -2.8 to -1.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.342
    Estimation Comments
    2. Secondary Outcome
    Title Mean Diurnal IOP at Week 6
    Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was used for the analyses.
    Time Frame Week 6

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set with non-missing values
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Measure Participants 61 67
    Mean (Standard Deviation) [mmHg]
    17.1
    (2.96)
    19.4
    (3.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.15
    Confidence Interval (2-Sided) 95%
    -2.8 to -1.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.342
    Estimation Comments
    3. Secondary Outcome
    Title Mean Percentage Change From Baseline in Diurnal IOP at Week 6
    Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
    Time Frame Baseline, Week 6

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Measure Participants 61 67
    Mean (Standard Deviation) [percentage change]
    -20.7
    (12.00)
    -11.1
    (13.86)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -9.98
    Confidence Interval (2-Sided) 95%
    -13.1 to -6.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.572
    Estimation Comments
    4. Secondary Outcome
    Title Mean Change From Baseline in IOP (09:00, 11:00) at Week 6
    Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
    Time Frame Baseline, Week 6

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Measure Participants 67 67
    Baseline 9:00 Hr
    22.2
    (1.84)
    22.5
    (1.80)
    Baseline 11:00 Hr
    21.4
    (1.93)
    21.4
    (2.26)
    Change from Baseline 9:00 Hr
    -4.4
    (3.07)
    -3.2
    (3.40)
    Change from Baseline 11:00 Hr
    -5.4
    (2.84)
    -2.5
    (2.98)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments Change from Baseline in IOP at 9:00
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.022
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.33
    Confidence Interval (2-Sided) 95%
    -2.5 to -0.2
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.576
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments Change from Baseline in IOP at 11:00
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.85
    Confidence Interval (2-Sided) 95%
    -3.9 to -1.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.506
    Estimation Comments
    5. Secondary Outcome
    Title Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6
    Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.
    Time Frame Baseline, Week 6

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included in the calculation of change.
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase) Brinzolamide/brimonidine vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00 hrs) plus travoprost 0.004%/timolol 0.5% solution, 1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for 42 days (Treatment Phase)
    Measure Participants 61 67
    Percent change at 9:00 Hr
    -20.2
    (13.56)
    -14.1
    (15.10)
    Percent change at 11:00 Hr
    -25.0
    (12.73)
    -11.7
    (13.63)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments Percentage Change from Baseline in IOP at 09:00
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -6.15
    Confidence Interval (2-Sided) 95%
    -11.2 to -1.1
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.567
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Simbrinza + Duotrav, Vehicle + Duotrav
    Comments Percentage Change from Baseline in IOP at 11:00
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Repeated measures model
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -13.21
    Confidence Interval (2-Sided) 95%
    -17.8 to -8.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.340
    Estimation Comments

    Adverse Events

    Time Frame Baseline through study completion, an average of 42 days
    Adverse Event Reporting Description An Adverse Event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Includes all subjects who received a dose of masked investigational product (Safety Analysis Set).
    Arm/Group Title Simbrinza + Duotrav Vehicle + Duotrav
    Arm/Group Description All subjects exposed to brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension plus travoprost 0.004%/timolol 0.5% solution All subjects exposed to brinzolamide/brimonidine vehicle plus travoprost 0.004%/timolol 0.5% solution
    All Cause Mortality
    Simbrinza + Duotrav Vehicle + Duotrav
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/67 (0%) 0/67 (0%)
    Serious Adverse Events
    Simbrinza + Duotrav Vehicle + Duotrav
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/67 (0%) 1/67 (1.5%)
    Renal and urinary disorders
    Dysuria 0/67 (0%) 1/67 (1.5%)
    Other (Not Including Serious) Adverse Events
    Simbrinza + Duotrav Vehicle + Duotrav
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/67 (0%) 0/67 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

    Results Point of Contact

    Name/Title WW Brand Medical Director Ophtha, GMA Ophthalmics
    Organization Alcon, A Novartis Division
    Phone 1-888-451-3937
    Email alcon.medinfo@alcon.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02730871
    Other Study ID Numbers:
    • GLJ576-P001
    • 2016-000176-20
    First Posted:
    Apr 7, 2016
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019