MedTrace Logo

Trial Outcomes & Findings for DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation (NCT NCT02517567)

NCT ID: NCT02517567

Last Updated: 2018-07-02

Results Overview

Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

Day 1, Hour 8, each product

Results posted on

2018-07-02

Participant Flow

Subjects were recruited from 1 study center located in Australia.

Of the 37 enrolled, 7 subjects were exited as screen failures prior to randomization and 1 subject discontinued after randomization prior to exposure to the investigational product. This reporting group includes all randomized and exposed subjects (29).

Participant milestones

Participant milestones
Measure
Sequence 1
DAILIES TOTAL1 (DT1)/TruEye/clariti/No Lens
Sequence 2
TruEye/No Lens/DT1/clariti
Sequence 3
clariti/DT1/No Lens/TruEye
Sequence 4
No Lens/clariti/TruEye/DT1
First Exposure (8 Hours)
STARTED
6
8
7
8
First Exposure (8 Hours)
COMPLETED
6
8
7
8
First Exposure (8 Hours)
NOT COMPLETED
0
0
0
0
Second Exposure (8 Hours)
STARTED
6
8
7
8
Second Exposure (8 Hours)
COMPLETED
6
8
7
8
Second Exposure (8 Hours)
NOT COMPLETED
0
0
0
0
Third Exposure (8 Hours)
STARTED
6
8
7
8
Third Exposure (8 Hours)
COMPLETED
6
8
7
8
Third Exposure (8 Hours)
NOT COMPLETED
0
0
0
0
Fourth Exposure (8 Hours)
STARTED
6
8
6
8
Fourth Exposure (8 Hours)
COMPLETED
6
8
6
8
Fourth Exposure (8 Hours)
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=29 Participants
Delefilcon A, narafilcon A, and somofilcon A contact lenses worn bilaterally (in both eyes) and a period of no lens wear in a randomized crossover fashion
Age, Continuous
23.7 years
STANDARD_DEVIATION 5.36 • n=99 Participants
Sex: Female, Male
Female
21 Participants
n=99 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Day 1, Hour 8, each product

Population: This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported.

Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Outcome measures

Outcome measures
Measure
Lens
n=172 Eyes
Delefilcon A contact lenses, narafilcon A contact lenses, and somofilcon A contact lenses worn bilaterally in cross-over fashion as randomized. Each product worn for one day, 8 hours minimum.
No Lens
n=58 Eyes
One 8-hour day of no lens wear as part of the crossover sequence
Tear Film Evaporation Rate
120.88 gm^-2 h
Standard Deviation 45.563
105.63 gm^-2 h
Standard Deviation 53.361

Adverse Events

Pretreatment

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

DAILIES TOTAL1

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

TruEye

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

Clariti

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

No Lens

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

Sr Global Brand Medical Affairs Lead, GCRA

Alcon, A Novartis Division

Phone: 1-888-451-3937

Results disclosure agreements

  • Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
  • Publication restrictions are in place

Restriction type: OTHER