Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics

• Sponsor: COA Research Foundation, INC (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01450787
• Collaborator: Allergan (Industry)
• Enrollment: 63
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 12.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 63 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
diabetics diabetics
non diabetics non diabetics

Outcome Measures

Primary Outcome Measures

1. Conjunctival Staining Score [at the time of the evaluation]

   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.

Secondary Outcome Measures

1. Tear Film Osmolarity [at the time of the exam]

   The tear film osmolarity is measured at the time of the exam.

Other Outcome Measures

1. OSDI Score [at the time of the exam]

   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.

2. Schirmer Score [at the time of the exam]

   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.

3. Tear Break-up Time [at the time of the exam]

   The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.

4. Corneal Staining [at the time of the exam]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbus Ophthalmalogy Associates	Columbus	Ohio	United States	43213

Sponsors and Collaborators

• COA Research Foundation, INC
• Allergan

Investigators

• Principal Investigator: Kenneth A Beckman, MD, COA Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: COA Research Foundation, INC
• ClinicalTrials.gov Identifier: NCT01450787
• Other Study ID Numbers: 000322
• First Posted: Oct 12, 2011
• Last Update Posted: Sep 30, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by COA Research Foundation, INC: dry eyes; diabetes
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled randomly. Consecutive patients in a private ophthalmology clinic that met inclusion criteria were asked to participate at the time of an already scheduled exam. The non-diabetic group recruitment stopped once the target number of subjects enrolled. The diabetic group recruitment continued until the study was terminated.
Pre-assignment Detail	Being that there was no intervention and the study only involved taking measurements at the time of the exam, there was no transition required. Any eligible patient that was willing to participate was included. Consecutive diabetic patients and consecutive non-diabetic patients that met criteria were offered the opportunity to enroll.

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Period Title: Overall Study
STARTED	38	25
COMPLETED	38	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Diabetics	Non Diabetics	Total
Arm/Group Description	diabetics over age 40	non diabetics over age 40	Total of all reporting groups
Overall Participants	38	25	63
Age, Customized (participants) [Number]
Number [participants]	38 100%	25 100%	63 100%
Sex: Female, Male (Count of Participants)
Female	22 57.9%	21 84%	43 68.3%
Male	16 42.1%	4 16%	20 31.7%
Region of Enrollment (participants) [Number]
United States	38 100%	25 100%	63 100%

Outcome Measures

1. Primary Outcome

Title	Conjunctival Staining Score
Description	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.
Time Frame	at the time of the evaluation

Outcome Measure Data

Analysis Population Description

There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Measure Participants	38	25
Measure eyes	76	50
Mean (Standard Error) [units on a scale]	2.72 (0.16)	2.19 (0.19)

2. Secondary Outcome

Title	Tear Film Osmolarity
Description	The tear film osmolarity is measured at the time of the exam.
Time Frame	at the time of the exam

Outcome Measure Data

Analysis Population Description

Tear film osmolarity was measured in all patients, but two patients in the diabetic group had an insufficient tear film to obtain a reading. Therefore, only 36 diabetics were included.

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Measure Participants	36	25
Measure eyes	72	50
Mean (Standard Error) [mOsml/L]	303.41 (2.03)	312.06 (3.05)

3. Other Pre-specified Outcome

Title	OSDI Score
Description	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.
Time Frame	at the time of the exam

Outcome Measure Data

Analysis Population Description

All patients completed the OSDI survey

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Measure Participants	38	25
Mean (Standard Error) [units on a scale]	19.58 (2.62)	27.50 (4.60)

4. Other Pre-specified Outcome

Title	Schirmer Score
Description	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.
Time Frame	at the time of the exam

Outcome Measure Data

Analysis Population Description

Each patient underwent schirmer testing

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Measure Participants	38	25
Measure eyes	76	50
Mean (Standard Error) [mm]	18.36 (1.06)	15.88 (1.34)

5. Other Pre-specified Outcome

Title	Tear Break-up Time
Description	The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.
Time Frame	at the time of the exam

Outcome Measure Data

Analysis Population Description

Each patient underwent tear break-up time testing

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Measure Participants	38	25
Measure eyes	76	50
Mean (Standard Error) [seconds]	3.38 (0.17)	3.66 (0.26)

6. Other Pre-specified Outcome

Title	Corneal Staining
Description	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.
Time Frame	at the time of the exam

Outcome Measure Data

Analysis Population Description

All patients underwent corneal staining evaluations using fluorescein.

Arm/Group Title	Diabetics	Non Diabetics
Arm/Group Description	diabetics over age 40	non diabetics over age 40
Measure Participants	38	25
Measure eyes	76	50
Mean (Standard Error) [units on a scale]	0.31 (0.08)	0.30 (0.13)

Adverse Events

Arm/Group Title	Diabetics		Non Diabetics
Arm/Group Description	diabetics over age 40		non diabetics over age 40
All Cause Mortality
	Diabetics		Non Diabetics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Diabetics		Non Diabetics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Diabetics		Non Diabetics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.