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

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ClinicalTrials.gov Identifier: NCT02730871
Recruitment Status : Terminated (Enrollment Challenges)
First Posted : April 7, 2016
Results First Posted : May 17, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 7, 2016
Results First Submitted Date  ICMJE April 23, 2019
Results First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE June 24, 2016
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
Change from Baseline in Diurnal IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
Change History Complete list of historical versions of study NCT02730871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Mean Diurnal IOP at Week 6 [ Time Frame: 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.
  • Mean Percentage Change From Baseline in Diurnal IOP at Week 6 [ Time Frame: 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.
  • Mean Change From Baseline in IOP (09:00, 11:00) at Week 6 [ Time Frame: 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.
  • Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Diurnal IOP at Week 6 [ Time Frame: Week 6 ]
  • Percentage Change from Baseline in Diurnal IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
  • Change from Baseline in IOP for Each Time Point (09:00, 11:00, 15:00) at Week 6 [ Time Frame: Baseline, Week 6 ]
  • Percentage Change from Baseline in IOP for Each Time Point (09:00, 11:00, 15:00) at Week 6 [ Time Frame: Baseline, Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®
Official Title  ICMJE Safety and Efficacy With Twice Daily Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) as an Adjunctive Therapy to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®)
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.
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 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 tartrate 0.2% ophthalmic suspension
    Other Name: SIMBRINZA® suspension
  • 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 Name: DUOTRAV®
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
    • Drug: Travoprost 0.004%/timolol 0.5% solution
  • 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)
    Interventions:
    • Drug: Brinzolamide/brimonidine vehicle
    • Drug: Travoprost 0.004%/timolol 0.5% solution
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 7, 2018)
173
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
300
Actual Study Completion Date  ICMJE July 13, 2018
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT02730871
Other Study ID Numbers  ICMJE GLJ576-P001
2016-000176-20 ( EudraCT Number )
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: Assoc Global Trial Director, TM Ophtha Alcon Research
PRS Account Alcon Research
Verification Date May 2019

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