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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

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.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension Drug: Brinz/brim vehicle Drug: Prostaglandin analogue Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
Actual Study Start Date : August 7, 2015
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 27, 2018


Arm Intervention/treatment
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
Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Other Name: SIMBRINZA® suspension

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%)

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
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%)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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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 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.

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): NCT02419508


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Manager, Ophtha, GCRA Alcon, a Novartis Company
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Statistical Analysis Plan  [PDF] March 12, 2018
Study Protocol  [PDF] March 30, 2017


Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02419508     History of Changes
Other Study ID Numbers: GLH694-P001
2015-000736-15 ( EudraCT Number )
REec-2015-1723 ( Registry Identifier: Registro Espanol de Estudios Clinicos )
First Posted: April 17, 2015    Key Record Dates
Results First Posted: November 15, 2018
Last Update Posted: November 15, 2018
Last Verified: November 2018
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
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
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