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The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure

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ClinicalTrials.gov Identifier: NCT02165631
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and nocturnal periods. The primary aim of this study will be to determine the effects of Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to compare these to those of timolol.

Condition or disease
Open Angle Glaucoma Ocular Hypertension Pigment Dispersion Syndrome Pseudoexfoliation Glaucoma

Detailed Description:
Intraocular pressure (IOP) is a major risk factor for the development of glaucoma. In addition, it is the only modifiable factor in the prevention and subsequent treatment of glaucomatous optic neuropathy. Most clinicians only have access to a single IOP measurement during a patient visit that may only occur once every four months. These snapshots in time are probably not adequate for the optimal management of glaucoma. Diurnal IOP curves can provide a better estimate of each patient's individual IOP variation throughout the day. However diurnal curves do not typically cover another crucial time, the nocturnal period. Glaucomatous eyes have been shown to have different IOP curves during the nocturnal period compared to healthy controls. In addition, different classes of glaucoma drugs have variable IOP lowering effects during the nocturnal hours compared to the diurnal/wake period. For example, the betablocker timolol was shown to lower IOP during daytime hours but failed to lower IOP during the nocturnal period in the habitual position. Similarly, the alpha-agonist brimonidine failed to lower IOP overnight after significantly lowering IOP during the diurnal period. On the other hand, the prostaglandin analogues, including latanoprost and travoprost, lowered IOP throughout the diurnal and nocturnal periods although nocturnal lowering appears less than the daytime hours. Therefore it is crucial to determine an accurate IOP curve for each form of medication during both wake and sleep hours.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure
Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Group/Cohort
Group A-Simbinza
Patients in Group A will receive Simbrinza (brinzolamide) 1%/0.2%, with instruction for three times daily (every 8hours) administration of the medication in both eyes for a minimum of 4 weeks and a maximum of 8 weeks of medication therapy.
Group B-Timolol
Patients in Group B will receive Timolol 0.5%, with instructions for twice daily administration (every 12 hours) of the medication in both eyes for a minimum of 4 weeks and a maximum of 8 weeks of medication therapy.



Primary Outcome Measures :
  1. Intraocular pressure Group A [ Time Frame: 24 hours ]
    The primary outcome measure will be the change in intraocular pressure and ocular perfusion pressure after 4 weeks of Simbrinza therapy at multiple time points throughout a 24-hour period.


Secondary Outcome Measures :
  1. Intraocular pressure Group B [ Time Frame: 24 hours ]
    The secondary outcome measure will be the change in intraocular pressure and ocular perfusion pressure after 4 weeks of timolol therapy at multiple time points throughout a 24-hour period, and how this compares to similar effects by Simbrinza.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Open angle glaucoma, Ocular hypertension,Pigment dispersion glaucoma, or Pseudoexfoliation glaucoma
Criteria

Inclusion Criteria:

  • Diagnosis of open angle glaucoma or ocular hypertension including pigment dispersion glaucoma and pseudoexfoliation glaucoma.
  • Age ≥ 18 years, of either gender, or any race/ethnicity

Exclusion Criteria:

  • Females who are currently pregnant or planning to become pregnant during the study period
  • Contraindications to beta blockers (see below)
  • Patients currently taking oral beta blocker therapy
  • Diagnosis of any other form of glaucoma other than open-angle
  • Schaffer angle grade < 2 in either eye by gonioscopy
  • Intraocular surgery within 6 months or laser within 3 months
  • Inability to safely discontinue all ocular medications for 6 weeks
  • Patients who smoke or have irregular daily sleep patterns
  • History of allergy or intolerance to topical carbonic anhydrase inhibitors, or alpha-agonists
  • Patients who have started or changed glucocorticoids therapy in the last 3 months
  • Patients who are currently using medical or recreational marijuana
  • Any use of a non-FDA approved medication for glaucoma in the last 3 months

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): NCT02165631


Locations
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United States, Colorado
University of Colorado Eye Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Malik Y Kahook, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02165631     History of Changes
Other Study ID Numbers: 14-0362
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Iris Diseases
Uveal Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents