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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

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
Open-angle Glaucoma Ocular Hypertension 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).

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Study Type : Interventional  (Clinical Trial)
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 : June 24, 2016
Actual Primary Completion Date : July 13, 2018
Actual Study Completion Date : July 13, 2018


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 Name: 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 Name: 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 Name: DUOTRAV®




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 [ 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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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:

  • 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.

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): NCT02730871


Locations
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United States, Texas
Contact Alcon for Locations (Europe, Asia, and Latin America)
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Assoc Global Trial Director, TM Ophtha Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] April 10, 2017
Statistical Analysis Plan  [PDF] July 23, 2018


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02730871     History of Changes
Other Study ID Numbers: GLJ576-P001
2016-000176-20 ( EudraCT Number )
First Posted: April 7, 2016    Key Record Dates
Results First Posted: May 17, 2019
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Brimonidine Tartrate
Glaucoma, Open-Angle
Ocular Hypertension
Glaucoma
Eye Diseases
Timolol
Travoprost
Cloprostenol
Pharmaceutical Solutions
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents