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

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension

• Registration Number: NCT01779778
• Lead Sponsor: University of Colorado, Denver

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.

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Intraocular Pressure	Every 2 hours for 24 hours	To determine the 24-hour intraocular pressure lowering effect of Travatan Z

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure Change Duration	72 hours	Elucidate the duration of effect from Travatan Z administration which may lead to more efficient dosing regimens

Trial Locations

Locations (1)

University of Colorado Eye Center; 🇺🇸 Aurora, Colorado, United States