Trial Outcomes & Findings for Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type (NCT NCT04105842)

NCT ID: NCT04105842

Last Updated: 2023-07-25

Results Overview

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Day 1 after screening with habitual lenses
• Results posted on: 2023-07-25

Participant Flow

Participants were recruited at a single site between September 2019 and June 2022. The first participant was enrolled on September 23, 2019 and the last participant was enrolled on June 23, 2022.

Out of 40 participants enrolled, 37 met the inclusion criteria.

Participant milestones

Measure	Delefilcon A All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis.
Overall Study STARTED	37
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Delefilcon A All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type

Baseline characteristics by cohort

Measure	Delfilcon A n=37 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 after screening with habitual lenses

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	72.5 score on a scale Interval 20.0 to 90.0

PRIMARY outcome

Timeframe: Day 3 after screening with habitual lenses

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	73.5 score on a scale Interval 20.0 to 100.0

PRIMARY outcome

Timeframe: Day 5 after screening with habitual lenses

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 20.0 to 100.0

PRIMARY outcome

Timeframe: 1-week follow up with habitual lens

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	75 score on a scale Interval 25.0 to 90.0

PRIMARY outcome

Timeframe: Day 1 after dispense with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	85 score on a scale Interval 20.0 to 100.0

PRIMARY outcome

Timeframe: Day 3 after dispense with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 35.0 to 100.0

PRIMARY outcome

Timeframe: Day 5 after dispense with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 7 after dispense with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 21 after dispense with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 50.0 to 100.0

PRIMARY outcome

Timeframe: Day 28 after dispense with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 30.0 to 100.0

PRIMARY outcome

Timeframe: 1-month follow up with delefilcon A

Participants rate their end of day comfort on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Comfort at End of Day With Contact Lens Wear	80 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 1 after screening with habitual lenses

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	70 score on a scale Interval 10.0 to 90.0

PRIMARY outcome

Timeframe: Day 3 after screening with habitual lenses

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	70 score on a scale Interval 20.0 to 100.0

PRIMARY outcome

Timeframe: Day 5 after screening with habitual lenses

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	70 score on a scale Interval 25.0 to 100.0

PRIMARY outcome

Timeframe: 1-week follow up with habitual lens

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	70 score on a scale Interval 20.0 to 95.0

PRIMARY outcome

Timeframe: Day 1 after dispense with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	80 score on a scale Interval 30.0 to 100.0

PRIMARY outcome

Timeframe: Day 3 after dispense with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	80 score on a scale Interval 20.0 to 100.0

PRIMARY outcome

Timeframe: Day 5 after dispense with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	75 score on a scale Interval 35.0 to 100.0

PRIMARY outcome

Timeframe: Day 7 after dispense with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	70 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 21 after dispense with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	80 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 28 after dispense with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	80 score on a scale Interval 20.0 to 100.0

PRIMARY outcome

Timeframe: 1-month follow up with delefilcon A

Participants rate their end of day dryness on a scale from 0 (worst) to 100 (best).

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Subjective Rating of End of Day Dryness With Contact Lens Wear	80 score on a scale Interval 40.0 to 100.0

PRIMARY outcome

Timeframe: Day 1 after screening with habitual lenses

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	10.9 hours per day Interval 6.0 to 18.0

PRIMARY outcome

Timeframe: Day 3 after screening with habitual lenses

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	11.4 hours per day Interval 6.0 to 18.4

PRIMARY outcome

Timeframe: Day 5 after screening with habitual lenses

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	11.4 hours per day Interval 6.0 to 17.5

PRIMARY outcome

Timeframe: 1-week follow up with habitual lens

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	12 hours per day Interval 3.2 to 16.5

PRIMARY outcome

Timeframe: Day 1 after dispense with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	11.0 hours per day Interval 6.7 to 17.4

PRIMARY outcome

Timeframe: Day 3 after dispense with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	10.4 hours per day Interval 5.5 to 18.1

PRIMARY outcome

Timeframe: Day 5 after dispense with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	12.0 hours per day Interval 6.0 to 17.5

PRIMARY outcome

Timeframe: Day 7 after dispense with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	11.7 hours per day Interval 6.0 to 18.0

PRIMARY outcome

Timeframe: Day 21 after dispense with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	12.1 hours per day Interval 6.0 to 17.3

PRIMARY outcome

Timeframe: Day 28 after dispense with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	12.0 hours per day Interval 4.3 to 17.2

PRIMARY outcome

Timeframe: 1-month follow up with delefilcon A

Average lens wear time is recorded

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Average Lens Wear Time	12.5 hours per day Interval 6.5 to 17.0

PRIMARY outcome

Timeframe: Day 1 after screening with habitual lenses

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	7.0 hours per day Interval 1.0 to 14.6

PRIMARY outcome

Timeframe: Day 3 after screening with habitual lenses

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	6.8 hours per day Interval 0.8 to 15.5

PRIMARY outcome

Timeframe: Day 5 after screening with habitual lenses

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	6.4 hours per day Interval 1.3 to 15.3

PRIMARY outcome

Timeframe: 1-week follow up with habitual lens

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=36 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	6.0 hours per day Interval 1.0 to 12.5

PRIMARY outcome

Timeframe: Day 1 after dispense with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	7.5 hours per day Interval 1.2 to 15.5

PRIMARY outcome

Timeframe: Day 3 after dispense with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	7.0 hours per day Interval 1.2 to 18.1

PRIMARY outcome

Timeframe: Day 5 after dispense with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	7.5 hours per day Interval 0.8 to 17.5

PRIMARY outcome

Timeframe: Day 7 after dispense with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	8.1 hours per day Interval 2.3 to 16.1

PRIMARY outcome

Timeframe: Day 21 after dispense with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	7.3 hours per day Interval 0.9 to 16.7

PRIMARY outcome

Timeframe: Day 28 after dispense with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	7.3 hours per day Interval 1.0 to 17.2

PRIMARY outcome

Timeframe: 1-month follow up with delefilcon A

Comfortable lens wear time (Time of discomfort - Time of insertion)

Outcome measures

Measure	Delfilcon A n=35 Participants All study participants will be refit with Delfilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delfilcon A: Participants wear delafilcon A contact lenses on a daily disposable basis.
Comfortable Lens Wear Time	8.5 hours per day Interval 1.0 to 17.0

Adverse Events

Ocular Adverse Events Only: Habitual Contact Lenses

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ocular Adverse Events Only: Delefilcon A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Systemic Adverse Events: Habitual Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Systemic Adverse Events: Delefilcon 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

Measure	Ocular Adverse Events Only: Habitual Contact Lenses n=37 participants at risk All study participants will wear their habitual daily disposable contact lenses for 6-14 days.	Ocular Adverse Events Only: Delefilcon A n=35 participants at risk All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis.	Systemic Adverse Events: Habitual Contact Lenses n=37 participants at risk All study participants will wear their habitual daily disposable contact lenses for 6-14 days.	Systemic Adverse Events: Delefilcon A n=35 participants at risk All study participants will be refit with Delefilcon A (Dailies Total 1) lenses which they will wear for 1 month. Delefilcon A: Participants wear delefilcon A contact lenses on a daily disposable basis
Eye disorders Stye	2.7% 1/37 • Number of events 1 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/35 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/37 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/35 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
Eye disorders Cyst	2.7% 1/37 • Number of events 1 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/35 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/37 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/35 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.
Eye disorders Foreign body trail	0.00% 0/37 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	2.9% 1/35 • Number of events 1 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/37 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.	0.00% 0/35 • Up to 35-48 days Regular investigator assessment. An adverse event was defined as any unfavourable and unintended sign, symptom, or disease temporarily associated with a study procedure, whether there was a causal relationship or not.

Additional Information

Jill Woods

Centre for Ocular Research and Education

Phone: 5198884567

Email: jwoods@uwaterloo.ca

Results disclosure agreements

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