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Completed

NCT Number: NCT01978600

Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
  • Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
  • Must sign an Informed Consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
  • Severe central visual field loss in either eye.
  • Chronic, recurrent or severe inflammatory eye disease.
  • Ocular trauma or ocular surgery within the past 6 months.
  • Ocular infection or ocular inflammation within the past 3 months.
  • Clinically significant or progressive retinal disease.
  • Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
  • Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
  • Any medical condition that would preclude the safe administration of a topical beta-blocker.
  • Cannot safely discontinue all glucocorticoids administered by any route.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension

Drug

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Other names: SIMBRINZA™

timolol maleate 0.5%

Drug

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Other names: TIMOPTIC™, TIMOPTIC-XE™, BETIMOL™, ISTALOL™

Primary outcomes

  1. Mean Nocturnal IOP at Week 4

    Time frame: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM

    Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. 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 at Week 4

    Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM

    Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

  2. Mean 24-hour IOP at Week 4

    Time frame: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM

    24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2013
Registry last updated
Apr 13, 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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