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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01779778
First received: January 28, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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. We 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. We further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.


Condition
Open Angle Glaucoma
Ocular Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    To determine the 24-hour intraocular pressure lowering effect of Travatan Z


Secondary Outcome Measures:
  • Intraocular Pressure Change Duration [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Elucidate the duration of effect from Travatan Z administration which may lead to more efficient dosing regimens


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with open angle glaucoma or ocular hypertension

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01779778

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

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01779778     History of Changes
Other Study ID Numbers: 12-0175
Study First Received: January 28, 2013
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014