Trial Outcomes & Findings for ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1® (NCT NCT02750813)

Results Overview

Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

252 participants

Primary outcome timeframe

Day 14, each product

Results posted on

2018-07-02

Participant Flow

Subjects were recruited from 12 study centers located in the United States.

Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246).

Participant milestones

Participant milestones
Measure	DT1, Then AO1D Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.	AO1D, Then DT1 Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Period 1, First 14 Days of Wear STARTED	125	121
Period 1, First 14 Days of Wear COMPLETED	124	120
Period 1, First 14 Days of Wear NOT COMPLETED	1	1
Period 2, Second 14 Days of Wear STARTED	124	120
Period 2, Second 14 Days of Wear COMPLETED	124	120
Period 2, Second 14 Days of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	DT1, Then AO1D Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.	AO1D, Then DT1 Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Period 1, First 14 Days of Wear Withdrawal by Subject	1	0
Period 1, First 14 Days of Wear Reason not given	0	1

Baseline Characteristics

ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=246 Participants Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	30.7 years STANDARD_DEVIATION 8.44 • n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14, each product

Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

Outcome measures

Outcome measures
Measure	DAILIES TOTAL1 n=488 Eyes Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality	AO1D n=488 Eyes Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14	100.0 percentage of lenses	99.4 percentage of lenses

SECONDARY outcome

Timeframe: Day 14, each product

Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site.

The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.

Outcome measures

Outcome measures
Measure	DAILIES TOTAL1 n=17 Eyes Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality	AO1D n=17 Eyes Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14	0.0468 unitless Standard Deviation 0.00557	0.0675 unitless Standard Deviation 0.00599

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DAILIES TOTAL1 (DT1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACUVUE OASYS 1-DAY (AO1D)

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

Franchise Head, Vision Care

Alcon, A Novartis Division

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