Assessing Ocular Surface Changes After Changing Glaucoma Medications

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00554411

First received: November 2, 2007

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2007

Last Updated Date

January 29, 2013

Start Date ^ICMJE

November 2007

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Signs and Symptoms of Ocular Surface Disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

measurable change in the tear film brek up time [ Time Frame: 6 weeks ]

Change History

Complete list of historical versions of study NCT00554411 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

measurable change in the corneal staining and the Ocular Surface Disease Index [ Time Frame: 6 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Assessing Ocular Surface Changes After Changing Glaucoma Medications

Official Title ^ICMJE

Assessing Changes at the Ocular Surface Following the Switch From Xalatan to Travatan Z.

Brief Summary

hypothesis: changing to Travatan Z therapy increases the tear film break up time of subjects on Xalatan therapy presenting with ocular surface disease.

Detailed Description

Patients who have been taking Xalatan monotherapy to treat their glaucoma and presenting with ocular surface disease will be advised to switch their medication to Travatan Z. Test results will be record at the day that the medication was changed and at follow-up to determine if there is a measurable change in tear film break up, corneal staining and in the Ocular Surface Disease Index.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients will be selected from the ophthalmology clinic of the principal investigator

Condition ^ICMJE

Glaucoma
Monotherapy With Xalatan From 1 to 18 Months
Ocular Surface Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

on Xalatan monotherapy from 1 t 18 months
18 years of age or older
has been diagnosed with ocular surface disease

Exclusion Criteria:

special populations such as children, pregnant females, prisoners, etc.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00554411

Other Study ID Numbers ^ICMJE

07-0757

Has Data Monitoring Committee

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Malik Y Kahook, M.D.

Rocky mountain Lions Eye Institute

Information Provided By

University of Colorado, Denver

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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