Trial Outcomes & Findings for Effect of TrueTear Corneal Surface Imaging (NCT NCT03637348)

Last Updated: 2020-08-11

Results Overview

Surface asymmetry index (SAI) is an index that indicates an average value of the corneal power differences between the points spatially located at 180° from 128 equidistant meridians. A radially symmetrical surface has a value of zero, and this value increases as the degree of asymmetry is greater. Higher values are worse, but there is no set maximum value and no unit of measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Change from baseline SAI at 5-10 minutes after using the TrueTear device.

Results posted on

2020-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	TrueTear Use of TrueTear device to stimulate tear production TrueTear: Use of TrueTear neurostimulator
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of TrueTear Corneal Surface Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TrueTear n=45 Participants Use of TrueTear device to stimulate tear production TrueTear: Ues of TrueTear neurostimulator
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline SAI at 5-10 minutes after using the TrueTear device.

Outcome measures

Outcome measures
Measure	TrueTear n=45 Participants Use of TrueTear device to stimulate tear production TrueTear: Ues of TrueTear neurostimulator
Surface Asymmetry Index (SAI) Assessed With Corneal Topography	0.21 unitless Standard Deviation 0.34

SECONDARY outcome

Timeframe: Change from baseline SRI at 5-10 minutes after using the TrueTear device.

Surface Regularity index (SRI) is a local descriptor of surface regularity in a central 4.5 mm diameter area of the cornea. It correlates well with the value of visual acuity (p = 0.80, P \<0.001), assuming the cornea is the only limiting factor for vision. A normal cornea presents SRI values below 0.56 (the SRI would be 0 in a perfectly regular cornea). SRI values increase with increasing irregularity of the corneal surface. Higher values are worse, but there is no set maximum value and no unit of measure.

Outcome measures

Outcome measures
Measure	TrueTear n=45 Participants Use of TrueTear device to stimulate tear production TrueTear: Ues of TrueTear neurostimulator
Surface Regularity Index (SRI) Assessed With Corneal Topography	0.1 unitless Standard Deviation 0.3

Adverse Events

TrueTear

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

Marianne Price, PhD

Cornea Research Foundation of America

Phone: 3178142990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place