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
Results First Received: July 7, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Dry Eye

  Participant Flow
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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
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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
  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
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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


  More Information
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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