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

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ClinicalTrials.gov Identifier: NCT01978600
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension Drug: Timolol Maleate 0.5% Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014


Arm Intervention/treatment
Experimental: SIMBRINZA™
Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Other Name: SIMBRINZA™

Active Comparator: Timolol Maleate 0.5%
Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
Drug: Timolol Maleate 0.5%
Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
Other Names:
  • TIMOPTIC™
  • TIMOPTIC-XE™
  • BETIMOL™
  • ISTALOL™




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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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:

  • 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.

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): NCT01978600


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Danyel Carr, MS Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01978600     History of Changes
Other Study ID Numbers: M-13-037
First Posted: November 7, 2013    Key Record Dates
Results First Posted: April 13, 2015
Last Update Posted: April 13, 2015
Last Verified: March 2015

Keywords provided by Alcon Research:
Open-Angle Glaucoma
Ocular Hypertension
Simbrinza™
Intraocular Pressure

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Brimonidine Tartrate
Maleic acid
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors