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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779778
• Other study ID #: 12-0175
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: July 29, 2016
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Locations

Country	Name	City	State
United States	University of Colorado Eye Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Intraocular Pressure	To determine the 24-hour intraocular pressure lowering effect of Travatan Z	Every 2 hours for 24 hours	No
Secondary	Intraocular Pressure Change Duration	Elucidate the duration of effect from Travatan Z administration which may lead to more efficient dosing regimens	72 hours	No