Trial Outcomes & Findings for Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms (NCT NCT00565669)

Last Updated: 2018-11-07

Results Overview

The Schirmer score is a score on a scale - minimum is 0 and the highest is 35 mm. Above 15 mm is normal and less than 5 is severe dry eyes. A positive score means there was an improvement, 0 will be no change from baseline and a negative one that there was a decreased in tears. This change was calculated by subtracting the baseline value from the 3 months value (3 mo Schirmer's - baseline Schirmer's = amount of change).

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

baseline to 3 months

Results posted on

2018-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Blink Tears	Systane
Overall Study STARTED	11	9
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blink Tears n=11 Participants	Systane n=9 Participants	Total n=20 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 9.7 • n=5 Participants	67.4 years STANDARD_DEVIATION 7.82 • n=7 Participants	66.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 3 months

Outcome measures

Outcome measures
Measure	Blink Tears n=11 Participants	Systane n=9 Participants
Change in Schirmer's Scores	-.30 score on a scale Standard Error 2.82	-1.06 score on a scale Standard Error 4.17

Adverse Events

Blink Years

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systane

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

Helga Sandoval

Carolina Eye

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place