Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Dry Eyes Clinical Trial

Official title:

Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01450787
• Other study ID #: 000322
• Status: Terminated
• Phase: N/A
• First received: October 10, 2011
• Last updated: August 8, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: August 2013
• Source: COA Research Foundation, INC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eyes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	Columbus Ophthalmalogy Associates	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
COA Research Foundation, INC	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OSDI Score	The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.	at the time of the exam	No
Other	Schirmer Score	The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.	at the time of the exam	No
Other	Tear Break-up Time	The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.	at the time of the exam	No
Other	Corneal Staining	Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.	at the time of the exam	No
Primary	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	No
Secondary	Tear Film Osmolarity	The tear film osmolarity is measured at the time of the exam.	at the time of the exam	No