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

January 28, 2013
March 25, 2014
April 2012
April 2013   (final data collection date for primary outcome measure)
Intraocular Pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
To determine the 24-hour intraocular pressure lowering effect of Travatan Z
Same as current
Complete list of historical versions of study NCT01779778 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure
The Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients diagnosed with open angle glaucoma or ocular hypertension

  • Open Angle Glaucoma
  • Ocular Hypertension
Not Provided
Not Provided
Seibold LK, Kahook MY. The diurnal and nocturnal effect of travoprost with sofZia on intraocular pressure and ocular perfusion pressure. Am J Ophthalmol. 2014 Jan;157(1):44-49.e1. doi: 10.1016/j.ajo.2013.09.001. Epub 2013 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01779778
12-0175
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Leonard Seibold, MD University of Colorado, Denver
University of Colorado, Denver
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP