Trial Outcomes & Findings for Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time (NCT NCT00854906)

NCT ID: NCT00854906

Last Updated: 2014-10-23

Results Overview

This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.

• Recruitment status: COMPLETED
• Target enrollment: 26 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2014-10-23

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study One person had no ocular history	1

Baseline Characteristics

Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

Baseline characteristics by cohort

Measure	All Study Participants n=26 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.6 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 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.

This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.

Outcome measures

Measure	KTBUT n=50 eyes	FTBUT n=50 eyes
Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)	5.95 time in seconds Standard Deviation 2.8	5.39 time in seconds Standard Deviation 2.57

SECONDARY outcome

Timeframe: 1 week

Population: 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.

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.

Outcome measures

Measure	KTBUT n=25 Participants	FTBUT
Ocular Surface Disease Index (OSDI) Questionnaire	9.4 participants Standard Deviation 9.1	—

Adverse Events

KTBUT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FTBUT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Harper

University of Arkansas for Medical Sciences

Phone: 501 526-6000

Email: harperricharda@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place