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Trial Outcomes & Findings for Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday (NCT NCT04037969)

NCT ID: NCT04037969

Last Updated: 2021-04-23

Results Overview

Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 15 minutes post-contact lens, 6 hours post-contact lens

Results posted on

2021-04-23

Participant Flow

Participant milestones

Participant milestones
Measure
Nesofilcon A/Delefilcon A
Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear
Delefilcon A/Nesofilcon A
Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear
Overall Study
STARTED
10
10
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nesofilcon A/Delefilcon A
n=10 Participants
Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear
Delefilcon A/Nesofilcon A
n=10 Participants
Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=10 Participants
10 Participants
n=10 Participants
19 Participants
n=20 Participants
Age, Categorical
>=65 years
1 Participants
n=10 Participants
0 Participants
n=10 Participants
1 Participants
n=20 Participants
Age, Continuous
31.2 years
STANDARD_DEVIATION 17.1 • n=10 Participants
25.1 years
STANDARD_DEVIATION 9.6 • n=10 Participants
28.2 years
STANDARD_DEVIATION 13.9 • n=20 Participants
Sex: Female, Male
Female
9 Participants
n=10 Participants
10 Participants
n=10 Participants
19 Participants
n=20 Participants
Sex: Female, Male
Male
1 Participants
n=10 Participants
0 Participants
n=10 Participants
1 Participants
n=20 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Canada
10 participants
n=10 Participants
10 participants
n=10 Participants
20 participants
n=20 Participants

PRIMARY outcome

Timeframe: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens

Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.

Outcome measures

Outcome measures
Measure
Full Group
n=20 Participants
Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear Delefilcon A: Silicone hydrogel contact lens for daily wear
Tear Evaporation Rate With Nesofilcon A
Baseline
0.81 % relative humidity per second
Standard Deviation 0.30
Tear Evaporation Rate With Nesofilcon A
15 minutes post-contact lenses
0.88 % relative humidity per second
Standard Deviation 0.32
Tear Evaporation Rate With Nesofilcon A
6 hours post-contact lenses
0.92 % relative humidity per second
Standard Deviation 0.38

PRIMARY outcome

Timeframe: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens

Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.

Outcome measures

Outcome measures
Measure
Full Group
n=20 Participants
Delefilcon A was worn in a randomly assigned eye and Nesofilcon A was worn in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear Delefilcon A: Silicone hydrogel contact lens for daily wear
Tear Evaporation Rate With Delefilcon A
Baseline
0.74 % relative humidity per second
Standard Deviation 0.21
Tear Evaporation Rate With Delefilcon A
15 minutes post-contact lenses
0.87 % relative humidity per second
Standard Deviation 0.24
Tear Evaporation Rate With Delefilcon A
6 hours post-contact lenses
0.95 % relative humidity per second
Standard Deviation 0.30

Adverse Events

Nesofilcon A/Delefilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delefilcon A/Nesofilcon A

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

Jill Woods

Centre for Ocular Research and Education

Phone: 5198884567

Results disclosure agreements

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