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Completed

NCT Number: NCT01937299

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

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®).

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension

Drug

Other names: SIMBRINZA®

Vehicle

Drug

Inactive ingredients used as a placebo comparator

Travoprost 0.004% ophthalmic solution

Drug

Other names: TRAVATAN Z®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination As Adjunctive Therapy to Travoprost

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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