Trial Outcomes & Findings for DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance (NCT NCT02235831)

NCT ID: NCT02235831

Last Updated: 2016-07-11

Results Overview

Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Day 5, each product
• Results posted on: 2016-07-11

Participant Flow

Subjects were recruited from 1 study center located in Spain.

Twenty-four subjects were enrolled; all enrolled subjects were also randomized. This reporting group includes all randomized subjects (24).

Participant milestones

Measure	Seq I DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	Seq 2 DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	Seq 3 DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	Seq 4 DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	Seq 5 DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.	Seq 6 DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
Period 1, First 5 Days of Wear STARTED	4	4	4	4	4	4
Period 1, First 5 Days of Wear COMPLETED	4	4	4	4	4	4
Period 1, First 5 Days of Wear NOT COMPLETED	0	0	0	0	0	0
Period 2, Second 5 Days of Wear STARTED	4	4	4	4	4	4
Period 2, Second 5 Days of Wear COMPLETED	4	4	4	4	4	4
Period 2, Second 5 Days of Wear NOT COMPLETED	0	0	0	0	0	0
Period 3, Third 5 Days of Wear STARTED	4	4	4	4	4	4
Period 3, Third 5 Days of Wear COMPLETED	4	4	4	4	4	4
Period 3, Third 5 Days of Wear NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

Baseline characteristics by cohort

Measure	Overall n=24 Participants DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
Age, Continuous	50.8 years STANDARD_DEVIATION 4.18 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5, each product

Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).

Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.

Outcome measures

Measure	Monovision n=24 Participants Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.	DACP MF n=24 Participants Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance Near	0.09 diopter*logMar	0.18 diopter*logMar
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance Intermediate	0.24 diopter*logMar	0.36 diopter*logMar

Adverse Events

Monovision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DACP MF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DACP MF (Low Add)

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

Sr. Global Brand Lead, GCRA, Vision Care

Alcon Research, Ltd.

Phone: 1-888-451-3937

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