Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854906
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : January 25, 2011
Last Update Posted : October 23, 2014
Information provided by:
University of Arkansas

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

  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
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] 
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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   26 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 39.6  (15.5) 
[Units: Participants]
Female   20 
Male   6 
Region of Enrollment 
[Units: Participants]
United States   26 

  Outcome Measures

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

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

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Richard Harper
Organization: University of Arkansas for Medical Sciences
phone: 501 526-6000 ext 2616

Responsible Party: Richard Harper, MD, Department of Ophthalmology, University of Arkansas for Medical Sciences Identifier: NCT00854906     History of Changes
Other Study ID Numbers: 109338
First Submitted: March 2, 2009
First Posted: March 3, 2009
Results First Submitted: July 7, 2010
Results First Posted: January 25, 2011
Last Update Posted: October 23, 2014