Trial Outcomes & Findings for Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal (NCT NCT02871375)

Results Overview

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

170 participants

Primary outcome timeframe

Day 14, each product

Results posted on

2018-07-02

Participant Flow

Subjects were recruited from 11 study centers located in the United States.

Of the 170 enrolled, 2 subjects were exited as screen failures prior to randomization. An additional 2 subjects were randomized in error but not exposed. This reporting group includes all randomized and exposed subjects (166).

Participant milestones

Participant milestones
Measure	DT1 MF / Habitual MF Delefilcon A multifocal (MF) contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.	Habitual MF / DT1 MF Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Period 1, First 14 Days of Wear STARTED	89	77
Period 1, First 14 Days of Wear COMPLETED	89	76
Period 1, First 14 Days of Wear NOT COMPLETED	0	1
Period 2, Second 14 Days of Wear STARTED	89	76
Period 2, Second 14 Days of Wear COMPLETED	89	76
Period 2, Second 14 Days of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	DT1 MF / Habitual MF Delefilcon A multifocal (MF) contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.	Habitual MF / DT1 MF Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Period 1, First 14 Days of Wear Inclusion criteria not met	0	1

Baseline Characteristics

Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=166 Participants Delefilcon A multifocal contact lenses and subject's habitual multifocal contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	52.0 years STANDARD_DEVIATION 5.14 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14, each product

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

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

Outcome measures

Outcome measures
Measure	DT1 MF n=152 Participants Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2	Habitual MF n=153 Participants Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)	-0.07 logMAR Standard Deviation 0.10	-0.09 logMAR Standard Deviation 0.10

SECONDARY outcome

Timeframe: Day 14, each product

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

The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.

Outcome measures

Outcome measures
Measure	DT1 MF n=165 Participants Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2	Habitual MF n=165 Participants Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2.
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score Period Two	11.6 units on a scale Standard Deviation 6.3	13.0 units on a scale Standard Deviation 6.2
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score Overall	10.7 units on a scale Standard Deviation 5.9	14.9 units on a scale Standard Deviation 6.9
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score Period One	9.9 units on a scale Standard Deviation 5.4	17.0 units on a scale Standard Deviation 7.1

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DT1 MF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Habitual MF

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