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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01779778

Enrollment

Registered

2013-01-30

Start date

2012-04-30

Completion date

2013-04-30

Last updated

2016-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results