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Completed

NCT Number: NCT02770248

24-hr Intraocular Pressure Control With SIMBRINZA ®

The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of either open-angle glaucoma or ocular hypertension;
  • Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
  • Willing and able to sign an informed consent form;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
  • Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
  • Ocular surgeries or procedures excluded by the protocol;
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
  • Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
  • Other protocol-specific exclusion criteria may apply.

Treatment and study plan

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Drug

Other names: SIMBRINZA ®

Vehicle

Drug

Inactive ingredients used as a placebo for masking purposes

Primary outcomes

  1. Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4

    Time frame: Baseline (Day 0), Week 4

    IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

Secondary outcomes

  1. Least Squares Mean Change From Baseline in Daytime IOP at Week 4

    Time frame: Baseline (Day 0), Week 4

    IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

  2. Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4

    Time frame: Baseline (Day 0), Week 4

    IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

  3. Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4

    Time frame: Baseline (Day 0), Week 4

    IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2016
Registry last updated
Jul 2, 2018

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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