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Trial Outcomes & Findings for Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment (NCT NCT03097614)

NCT ID: NCT03097614

Last Updated: 2018-10-18

Results Overview

Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

Day 45

Results posted on

2018-10-18

Participant Flow

Of the 57 enrolled subjects, 54 subjects completed the study. All 57 subjects enrolled in the study were included in FAS and safety populations

Participant milestones

Participant milestones
Measure
TrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Overall Study
STARTED
57
Overall Study
COMPLETED
54
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
TrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Overall Study
Adverse Event
3

Baseline Characteristics

Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TrueTear
n=57 Participants
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Age, Continuous
60.3 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
Sex/Gender, Customized
Female
43 Participants
n=5 Participants
Sex/Gender, Customized
Male
14 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
57 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

PRIMARY outcome

Timeframe: Day 45

Population: Of the 57 subjects that initiated the study, 48 subjects achieved the threshold and performed an application in the CAE at Day 45.

Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate "no discomfort" and 100 to indicate "maximal discomfort". The assessment line length of the scale will be 100 mm.

Outcome measures

Outcome measures
Measure
TrueTear
n=48 Participants
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Eye Dryness Score
48 Score on Scale
Standard Error 15.2

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

Therapeutic Area Head

Allergan Sales LLC

Phone: 877-277-8566

Results disclosure agreements

  • Principal investigator is a sponsor employee All data generated in this study is the property of Allergan. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Allergan
  • Publication restrictions are in place

Restriction type: OTHER