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Completed

NCT Number: NCT01779778

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Eye Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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