NCT01450787

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 30, 2013

Completed
Last Updated

September 30, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

October 10, 2011

Results QC Date

March 9, 2013

Last Update Submit

August 8, 2013

Conditions

Dry Eyes

Keywords

dry eyesdiabetes

Outcome Measures

Primary Outcomes (1)

  • Conjunctival Staining Score

    Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.

    at the time of the evaluation

Secondary Outcomes (1)

  • Tear Film Osmolarity

    at the time of the exam

Other Outcomes (4)

  • OSDI Score

    at the time of the exam

  • Schirmer Score

    at the time of the exam

  • Tear Break-up Time

    at the time of the exam

  • +1 more other outcomes

Study Arms (2)

diabetics

diabetics

non diabetics

non diabetics

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Existing clinic population from our practice

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbus Ophthalmalogy Associates

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Kenneth A Beckman, MD
Organization
Coa Research Foundation
kenbeckman22@aol.com
614-506-4720

Study Officials

  • Kenneth A Beckman, MD

    COA Research Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 12, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 30, 2013

Results First Posted

September 30, 2013

Record last verified: 2013-08

Locations

US(1)