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Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma

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ClinicalTrials.gov Identifier: NCT03150160
Recruitment Status : Completed
First Posted : May 12, 2017
Results First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE May 12, 2017
Results First Submitted Date  ICMJE October 19, 2018
Results First Posted Date  ICMJE February 25, 2019
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE September 21, 2017
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Mean Change From Baseline in Diurnal IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
a decrease in diurnal of intraocular pressure [ Time Frame: Baseline and Week 6 ]
To demonstrate that brinzolamide 1% / brimonidine 0.2%is superior to placebo in lowering diurnal intraocular pressure when added to baseline Travoprost therapy
Change History Complete list of historical versions of study NCT03150160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Percent Change From Baseline in IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
  • Mean Diurnal IOP at Week 6 [ Time Frame: Week 6 ]
    IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis.
  • Mean Change From Baseline in IOP for Each Time Point at Week 6 [ Time Frame: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am) ]
    IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
  • Percentage Change From Baseline in IOP for Each Time Point at Week 6 [ Time Frame: Baseline, Week 6 ]
    IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
  • a decrease in diurnal Intraocular pressure's percentage [ Time Frame: Baseline and week 6 ]
    To evaluate the differences between brinzolamide 1% / brimonidine 0.2% and placebo in diurnal intraocular pressure's percentage change from a travoprost baseline therapy
  • a decrease in diurnal intraocular pressure [ Time Frame: Week 6 ]
    To evaluate the differences between brinzolamide 1% / brimonidine 0.2% and placebo in diurnal intraocular pressure from a travoprost baseline therapy
  • a decrease from baseline in Intraocular pressure for each time point [ Time Frame: week 6 ]
    To evaluate the differences between brinzolamide 1% / brimonidine 0.2% and placebo in intraocular pressure change at each time point, from a travoprost baseline therapy
  • Percentage Change From Baseline in IOP for Each Time Point at Week 6 [ Time Frame: week 6 ]
    To evaluate the differences between brinzolamide 1% / brimonidine 0.2% and placebo in intraocular pressure percentage change at each time point, from a travoprost baseline therapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Official Title  ICMJE A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma
Brief Summary The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.
Detailed Description This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • Drug: brinzolamide 1%/brimonidine 0.2% fixed combination
    One drop applied topically to the affected eye(s) in the morning and evening
    Other Name: Simbrinza
  • Drug: Placebo
    One drop applied topically to the affected eye(s) in the morning and evening
  • Drug: travoprost 0.004% ophthalmic solution
    One drop applied topically to the affected eye(s) in the evening
    Other Name: Travatan
Study Arms  ICMJE
  • Experimental: Simbrinza + Travatan
    Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
    Interventions:
    • Drug: brinzolamide 1%/brimonidine 0.2% fixed combination
    • Drug: travoprost 0.004% ophthalmic solution
  • Placebo Comparator: Placebo + Travatan
    Placebo + travoprost 0.004% ophthalmic solution
    Interventions:
    • Drug: Placebo
    • Drug: travoprost 0.004% ophthalmic 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 Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2017)
200
Actual Study Completion Date  ICMJE December 4, 2017
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Sign written informed consent
  • Diagnosed with normal tension glaucoma
  • Intraocular pressure measurements in at least 1 eye as specified in the protocol
  • Willing and able to attend all study visits

Exclusion Criteria:

  • History of hypersensitivity to any of the study drugs
  • Use of medications prohibited by the protocol
  • Pregnant or nursing
  • Of child-bearing potential unless using contraception, as specified in the protocol
  • Any form of glaucoma other than open angle glaucoma in either eye
  • Chronic, recurrent or severe inflammatory eye disease
  • Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)
  • Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
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 Korea, Republic of
Removed Location Countries Canada,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT03150160
Other Study ID Numbers  ICMJE CQVJ499A2404
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2018

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