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Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779778
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : August 2, 2016
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.

Condition or disease
Open Angle Glaucoma Ocular Hypertension

Detailed Description:
The investigators hypothesize that Travatan Z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. The investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Primary Outcome Measures :
  1. Changes in Intraocular Pressure [ Time Frame: Every 2 hours for 24 hours ]
    To determine the 24-hour intraocular pressure lowering effect of Travatan Z

Secondary Outcome Measures :
  1. Intraocular Pressure Change Duration [ Time Frame: 72 hours ]
    Elucidate the duration of effect from Travatan Z administration which may lead to more efficient dosing regimens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (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 or ocular hypertension

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma
  • Age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity

Exclusion Criteria:

  • Females who are currently pregnant or planning to become pregnant, as determined by history during the study period
  • Diagnosis of any other form of glaucoma other than open-angle
  • Schaffer angle grade < 2 in either eye by gonioscopy
  • Chronic, recurrent, or severe inflammatory eye disease
  • Intraocular surgery within 6 months or laser within 3 months
  • History of active, recurrent, or chronic ocular infection with the Herpes Simplex Virus
  • History of cystoid macular edema
  • Inability to safely discontinue all ocular medications for 4 weeks
  • Patients who smoke or have irregular daily sleep patterns
  • Patients who have started or changed glucocorticoids therapy in the last 3 months
  • Patients who are currently undergoing medical marijuana therapy
  • 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 identifier (NCT number): NCT01779778

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United States, Colorado
University of Colorado Eye Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Leonard Seibold, MD University of Colorado, Denver

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT01779778     History of Changes
Other Study ID Numbers: 12-0175
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antihypertensive Agents