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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 )

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: brinzolamide 1%/brimonidine 0.2% fixed combination Drug: Placebo Drug: travoprost 0.004% ophthalmic solution Phase 4

Detailed Description:
This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
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
Official Title: 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
Actual Study Start Date : September 21, 2017
Actual Primary Completion Date : December 4, 2017
Actual Study Completion Date : December 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Simbrinza + Travatan
Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution
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: travoprost 0.004% ophthalmic solution
One drop applied topically to the affected eye(s) in the evening
Other Name: Travatan

Placebo Comparator: Placebo + Travatan
Placebo + travoprost 0.004% ophthalmic solution
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150160


Locations
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Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] April 9, 2018
Statistical Analysis Plan  [PDF] August 28, 2017


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03150160     History of Changes
Other Study ID Numbers: CQVJ499A2404
First Posted: May 12, 2017    Key Record Dates
Results First Posted: February 25, 2019
Last Update Posted: February 25, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
travoprost
brinzolamide 1%/brimonidine 0.2%
normal tension glaucoma
intraocular pressure
efficacy
safety

Additional relevant MeSH terms:
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Brimonidine Tartrate
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Travoprost
Brinzolamide
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors