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

NCT ID: NCT01779778

Last Updated: 2016-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leonard Seibold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Eye Center

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24182742 (View on PubMed)

Other Identifiers

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12-0175

Identifier Type: -

Identifier Source: org_study_id

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