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Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

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ClinicalTrials.gov Identifier: NCT00854906
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : January 25, 2011
Last Update Posted : October 23, 2014
Sponsor:
Information provided by:
University of Arkansas

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Dry Eye
Enrollment 26

Recruitment Details 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 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.
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 26 [1]
Completed 25 [2]
Not Completed 1
Reason Not Completed
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.
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
39.6  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
20
  76.9%
Male
6
  23.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)
Hide Description This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.
Time Frame 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined if each participant met all of the study protocol's inclusion and exclusion criteria. KTBUT and FTBUT were measured on all study participants.
Arm/Group Title KTBUT FTBUT
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 50
Mean (Standard Deviation)
Unit of Measure: time in seconds
5.95  (2.8) 5.39  (2.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KTBUT, FTBUT
Comments The paired T-test was used to compare mean KTBUT and mean FTBUT.
Type of Statistical Test Non-Inferiority or Equivalence
Comments This was a pilot study. Therefore, no formal power analyses were performed.
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.666
Confidence Interval (2-Sided) 95%
-0.069 to 1.401
Parameter Dispersion
Type: Standard Deviation
Value: 3.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Ocular Surface Disease Index (OSDI) Questionnaire
Hide Description The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used in dry eye studies. The OSDI Scale ranges from 0= Normal to 100= Severe. Subcategories include problems--all of the time, most of the time, half of the time,and none of the time.
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
By comparing the KTBUT and the FTBUT to the Ocular Surface Disease Index (OSDI) questionnaire score of each participant, we will be able to evaluate the difference in tear break up time using these items. The OSDI was given once before the participant's KTBUT and FTBUT was measured.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: participants
9.4  (9.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments A correlation was performed between ODSI questionnaire results and each participant's KTBUT.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis will evaluate the association between OSDI with KTBUT.
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method Pearson's correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson's Correlation, r
Estimated Value -0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Study Participants
Comments A correlation was performed between ODSI questionnaire results and each participant's FTBUT.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method Pearson's Correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson's Correlation, r
Estimated Value -0.26
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The number of participants at risk were 0. Serious and/or other [non-serious] adverse events were not collected or assessed. The study only required subjects to participate one time. There were not any follow-up visits.
 
Arm/Group Title KTBUT FTBUT
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
KTBUT FTBUT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
KTBUT FTBUT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
KTBUT FTBUT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
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
ClinicalTrials.gov 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