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

NCT01779778 | Completed

• 1 other identifier: 12-0175
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in Intraocular Pressure

  To determine the 24-hour intraocular pressure lowering effect of Travatan Z

  Every 2 hours for 24 hours

Secondary Outcomes (1)

• Intraocular Pressure Change Duration

  72 hours

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with open angle glaucoma or ocular hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Eye Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 24182742 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Leonard Seibold, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 30, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)