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SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

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ClinicalTrials.gov Identifier: NCT02419508
Recruitment Status : Completed
First Posted : April 17, 2015
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE April 17, 2015
Results First Submitted Date  ICMJE October 16, 2018
Results First Posted Date  ICMJE November 15, 2018
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE August 7, 2015
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6 [ Time Frame: Baseline, Week 6 ]
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
Mean change from baseline in diurnal IOP at Week 6 [ Time Frame: Baseline (Day 1 Treatment Phase), Week 6 ]
IOP averaged over the 09:00, 11:00, and 16:00 time points.
Change History Complete list of historical versions of study NCT02419508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • Mean Diurnal IOP at Week 6 [ Time Frame: Week 6 ]
    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.
  • Mean Percentage Change From Baseline in Diurnal IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
  • Mean Change From Baseline in IOP at 11:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
  • Mean Percentage Change From Baseline in IOP at 11:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
  • Mean Change From Baseline in IOP at 09:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
  • Mean Percentage Change From Baseline at 09:00 at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Mean Diurnal IOP at Week 6 [ Time Frame: Week 6 ]
    IOP averaged over the 09:00, 11:00, and 16:00 time points.
  • Mean Percentage Change From Baseline in Diurnal IOP at Week 6 [ Time Frame: Baseline (Day 1 Treatment Phase), Week 6 ]
    IOP averaged over the 09:00, 11:00, and 16:00 time points.
  • Mean change from baseline in IOP for each time point (09:00, 11:00, 16:00) at Week 6 [ Time Frame: Baseline (Day 1 Treatment Phase), Week 6 ]
  • Mean percentage change from baseline in IOP for each time point (09:00, 11:00, 16:00) at Week 6 [ Time Frame: Baseline (Day 1 Treatment Phase), Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Official Title  ICMJE Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
Brief Summary The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.
Detailed Description This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
    Other Name: SIMBRINZA® suspension
  • Drug: Brinz/brim vehicle
    Inactive ingredients used as a placebo for masking purposes
  • Drug: Prostaglandin analogue
    Other Names:
    • TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%)
    • LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%)
    • XALATAN® (Latanoprost ophthalmic solution, 0.005%)
Study Arms  ICMJE
  • Experimental: SIMBRINZA + PGA
    Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
    Interventions:
    • Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
    • Drug: Prostaglandin analogue
  • Vehicle + PGA
    Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
    Interventions:
    • Drug: Brinz/brim vehicle
    • Drug: Prostaglandin analogue
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
290
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2015)
280
Actual Study Completion Date  ICMJE February 27, 2018
Actual Primary Completion Date February 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of either open-angle glaucoma or ocular hypertension;
  • Must sign an informed consent form;
  • Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00.
  • Willing and able to attend all study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
  • Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
  • Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
  • Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02419508
Other Study ID Numbers  ICMJE GLH694-P001
2015-000736-15 ( EudraCT Number )
REec-2015-1723 ( Registry Identifier: Registro Espanol de Estudios Clinicos )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Manager, Ophtha, GCRA Alcon, a Novartis Company
PRS Account Alcon Research
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP