Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses (NCT NCT01634659)

Results Overview

Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

330 participants

Primary outcome timeframe

Day 8

Results posted on

2013-12-24

Participant Flow

Participants were recruited from 18 study centers located in the US.

Of the 330 participants enrolled, 17 were exited from the study prior to randomization and dispense of product.This reporting group includes all randomized and dispensed participants (313).

Participant milestones

Participant milestones
Measure	Delefilcon A, Then Narafilcon B Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.	Narafilcon B, Then Delefilcon A Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Period 1 - First 8 Days of Wear STARTED	155	158
Period 1 - First 8 Days of Wear COMPLETED	155	158
Period 1 - First 8 Days of Wear NOT COMPLETED	0	0
Period 2 - Second 8 Days of Wear STARTED	155	158
Period 2 - Second 8 Days of Wear COMPLETED	152	158
Period 2 - Second 8 Days of Wear NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Delefilcon A, Then Narafilcon B Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.	Narafilcon B, Then Delefilcon A Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Period 2 - Second 8 Days of Wear Adverse Event	2	0
Period 2 - Second 8 Days of Wear Physician Decision	1	0

Baseline Characteristics

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delefilcon A, Then Narafilcon B n=155 Participants Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.	Narafilcon B, Then Delefilcon A n=158 Participants Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.	Total n=313 Participants Total of all reporting groups
Age, Continuous	31.9 years STANDARD_DEVIATION 10.0 • n=5 Participants	32.1 years STANDARD_DEVIATION 8.8 • n=7 Participants	32.0 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	120 Participants n=7 Participants	237 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8

Population: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.

Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	Delefilcon A n=301 Participants Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2	Narafilcon B n=301 Participants Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Overall Comfort	8.5 Units on a scale Standard Deviation 1.7	8.6 Units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Day 8

Population: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.

Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	Delefilcon A n=301 Participants Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2	Narafilcon B n=301 Participants Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Overall Quality of Vision	8.6 Units on a scale Standard Deviation 1.6	8.5 Units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Day 8

Population: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.

End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

Outcome measures

Outcome measures
Measure	Delefilcon A n=301 Participants Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2	Narafilcon B n=301 Participants Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
End of Day Comfort	7.7 Units on a scale Standard Deviation 2.2	7.9 Units on a scale Standard Deviation 1.9

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon B

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

Jami Kern, MBA, PhD

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

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