Trial Outcomes & Findings for DAILIES TOTAL1® Lubricity Post Wear (NCT NCT02072980)

Results Overview

Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Day 1 (for each period), 16 hours

Results posted on

2015-05-14

Participant Flow

Participants were recruited from 1 study center located in the US.

This reporting group includes all randomized participants (15).

Participant milestones

Participant milestones
Measure	16hr/15min Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.	15min/16hr Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
Period 1, First Wear STARTED	7	8
Period 1, First Wear COMPLETED	7	8
Period 1, First Wear NOT COMPLETED	0	0
Period 2, Second Wear STARTED	7	8
Period 2, Second Wear COMPLETED	7	7
Period 2, Second Wear NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	16hr/15min Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.	15min/16hr Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
Period 2, Second Wear Adverse Event	0	1

Baseline Characteristics

DAILIES TOTAL1® Lubricity Post Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=15 Participants Delefilcon A contact lenses worn during Period 1 and Period 2
Age, Continuous	44.9 years STANDARD_DEVIATION 10.91 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (for each period), 16 hours

Population: This analysis population includes all participants who completed the study.

Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

Outcome measures

Outcome measures
Measure	16 Hours n=14 Participants Delefilcon A contact lenses worn for 16 hours in Period 1 or 2	Unworn n=14 Participants Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn	0.0394 unitless Standard Deviation 0.0015	0.0396 unitless Standard Deviation 0.0027

SECONDARY outcome

Timeframe: Day 1 (for each period), 15 minutes

Population: This analysis population includes all participants who completed the study.

Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

Outcome measures

Outcome measures
Measure	16 Hours n=14 Participants Delefilcon A contact lenses worn for 16 hours in Period 1 or 2	Unworn Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
Average Coefficient of Friction at 15 Minutes	0.0392 unitless Standard Deviation 0.0017	—

Adverse Events

DAILIES TOTAL1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DAILIES TOTAL1 n=15 participants at risk Delefilcon A contact lenses worn during Period 1 and Period 2
Eye disorders Corneal infiltrates	6.7% 1/15 • Adverse events (AEs) were collected for the duration of the study (March 2014 - April 2014). This analysis population includes all participants exposed to the investigational product, based on treatment-specific exposure. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained as solicited comments from the study participants and as observations by the Investigator.
Eye disorders Ocular discomfort	6.7% 1/15 • Adverse events (AEs) were collected for the duration of the study (March 2014 - April 2014). This analysis population includes all participants exposed to the investigational product, based on treatment-specific exposure. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained as solicited comments from the study participants and as observations by the Investigator.

Additional Information

Cecile Maissa, Global Brand Medical Affairs Lead - Vision Care

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place