Trial Outcomes & Findings for Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use (NCT NCT06308666)

Results Overview

Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

Day 14+2

Results posted on

2025-10-31

Participant Flow

Participants were recruited at a single site between March 2024 and October 2024. The first participant was enrolled on March 18, 2024 and the last participant was enrolled on October 9, 2024.

Out of the 41 participants that were enrolled, 35 met the inclusion critieria, and 35 were dispensed with the study treatment.

Participant milestones

Participant milestones
Measure	Refit Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia
Overall Study STARTED	35
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Refit Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Refit n=35 Participants Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia
Age, Categorical <=18 years	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants
Age, Continuous	25.5 years STANDARD_DEVIATION 6.3 • n=35 Participants
Sex: Female, Male Female	29 Participants n=35 Participants
Sex: Female, Male Male	6 Participants n=35 Participants
Region of Enrollment Canada	35 participants n=35 Participants

PRIMARY outcome

Timeframe: Day 14+2

Population: 3 people discontinued before the study could be completed.

Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	Refit n=32 Participants Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia
Subjective Rating of Comfort After 8 Hours or More of Digital Device Use	96 score on a scale Interval 70.0 to 100.0

PRIMARY outcome

Timeframe: Day 14+2

Population: 3 people discontinued before the study could be completed.

Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	Refit n=32 Participants Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia
Subjective Rating of Dryness After 8 Hours or More of Digital Device Use	93 score on a scale Interval 50.0 to 100.0

PRIMARY outcome

Timeframe: Day 14+2

Population: 3 people discontinued before the study could be completed.

Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure	Refit n=32 Participants Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Delefilcon A contact lenses: Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia
Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use	95 score on a scale Interval 75.0 to 100.0

Adverse Events

Refit

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: (519) 888-4567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place