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Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®

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ClinicalTrials.gov Identifier: NCT01937299
Recruitment Status : Completed
First Posted : September 9, 2013
Results First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN Z®).

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open Angle Glaucoma Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension Drug: Vehicle Drug: Travoprost 0.004% ophthalmic solution Phase 4

Detailed Description:
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination As Adjunctive Therapy to Travoprost
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: SIMBRINZA
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Other Name: SIMBRINZA®

Drug: Travoprost 0.004% ophthalmic solution
Other Name: TRAVATAN Z®

Placebo Comparator: Vehicle
Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
Drug: Vehicle
Inactive ingredients used as a placebo comparator

Drug: Travoprost 0.004% ophthalmic solution
Other Name: TRAVATAN Z®




Primary Outcome Measures :
  1. Mean Diurnal Intraocular Pressure (IOP) at Week 6 [ Time Frame: Week 6 ]
    Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).


Secondary Outcome Measures :
  1. Mean Diurnal IOP Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
    Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.

  2. Mean Diurnal IOP Percentage Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
    Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.



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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 or ocular hypertension;
  • Mean IOP measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 8 AM while on travoprost monotherapy at 2 consecutive visits (Eligibility 1 and Eligibility 2);
  • Able to understand and sign Informed Consent form;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
  • Any form of glaucoma other than open angle glaucoma or ocular hypertension;
  • Severe central visual field loss;
  • Chronic, recurrent, or severe inflammatory eye disease;
  • Ocular trauma within the past 6 months;
  • Ocular infection or ocular inflammation within the past 3 months;
  • Best-corrected visual acuity score worse than approximately 20/80 Snellen;
  • Eye surgery within the past 6 months;
  • Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
  • Use of any additional topical or systemic ocular hypertensive medication during the study;
  • Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
  • Other protocol-defined 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): NCT01937299


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Steve Burmaster, PhD Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01937299     History of Changes
Other Study ID Numbers: M-13-019
First Posted: September 9, 2013    Key Record Dates
Results First Posted: May 14, 2015
Last Update Posted: May 14, 2015
Last Verified: April 2015

Keywords provided by Alcon Research:
glaucoma
prostaglandin analogue
brinzolamide
brimonidine

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Brimonidine Tartrate
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