Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

This study has been terminated.

(Principle investigator changed practice location and discontinued study)

Sponsor:

Collaborator:

Allergan

Information provided by (Responsible Party):

COA Research Foundation, INC

ClinicalTrials.gov Identifier:

NCT01450787

First received: October 10, 2011

Last updated: July 11, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 10, 2011

Last Updated Date

July 11, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01450787 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Official Title ^ICMJE

Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Brief Summary

The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater risk for dry eyes.

Detailed Description

Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Existing clinic population from our practice

Condition ^ICMJE

Dry Eyes

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

diabetics
diabetics
non diabetics
non diabetics

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

Terminated

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

50 patients with diabetes, 25 without diabetes over the age of 40

Exclusion Criteria:

current use of glaucoma drops or currently within the postoperative period from eye surgery

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01450787

Other Study ID Numbers ^ICMJE

000322

Has Data Monitoring Committee

Responsible Party

COA Research Foundation, INC

Study Sponsor ^ICMJE

COA Research Foundation, INC

Collaborators ^ICMJE

Allergan

Investigators ^ICMJE

Principal Investigator:

Kenneth A Beckman, MD

COA Research Foundation

Information Provided By

COA Research Foundation, INC

Verification Date

July 2012

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

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