Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

This study has been completed.

Sponsor:

Information provided by:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT00854906

First received: March 2, 2009

Last updated: January 25, 2011

Last verified: January 2011

History of Changes

Results First Received: July 7, 2010

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Condition:	Dry Eye

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All qualifying patients who were scheduled in the Jones Eye Institute Clinics for a complete eye exam were offered information about the study and invited to participate. Participants were recruited from February 29, 2009 to April 14, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who did not meet the study protocol's inclusion and exclusion criteria were not included the study or study data analysis. All subjects eyes were measured for first for KTBUT and second for FTBUT. Each measurement occured three times in each eye and the results were recorded in seconds during their office visit and averaged.

Reporting Groups

	Description
All Study Participants	These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants.

Participant Flow: Overall Study

	All Study Participants
STARTED	26 ^[1]
COMPLETED	25 ^[2]
NOT COMPLETED	1
One person had no ocular history	1

[1]	There were 26 participants whose eyes were measured in the KTBUT group.
[2]	There were 26 participants in this group. One person was excluded be causes of no ocular history.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
All Study Participants	These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm.

Baseline Measures

	All Study Participants
Number of Participants [units: participants]	26
Age [units: participants]
<=18 years	0
Between 18 and 65 years	26
>=65 years	0
Age [units: years] Mean ± Standard Deviation	39.6 ± 15.5
Gender [units: participants]
Female	20
Male	6
Region of Enrollment [units: participants]
United States	26

Outcome Measures

Show All Outcome Measures

1. Primary:

Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) [ Time Frame: 1 day ]

Show Outcome Measure 1

2. Secondary:

Ocular Surface Disease Index (OSDI) Questionnaire [ Time Frame: 1 week ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Richard Harper
Organization: University of Arkansas for Medical Sciences
phone: 501 526-6000 ext 2616
e-mail: harperricharda@uams.edu

No publications provided

Responsible Party:	Richard Harper, MD, Department of Ophthalmology, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier:	NCT00854906 History of Changes
Other Study ID Numbers:	109338
Study First Received:	March 2, 2009
Results First Received:	July 7, 2010
Last Updated:	January 25, 2011
Health Authority:	United States: Institutional Review Board

To Top