Trial Outcomes & Findings for Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses (NCT NCT02089191)

Results Overview

The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Day 1, Hour 12, each period

Results posted on

2015-05-15

Participant Flow

Subjects were recruited from 1 investigational site located in Germany.

Participant milestones

Participant milestones
Measure	DACP/MyDay Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2	MyDay/DACP Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
Period 1, First 12 Hours STARTED	16	15
Period 1, First 12 Hours COMPLETED	16	15
Period 1, First 12 Hours NOT COMPLETED	0	0
Period 2, Second 12 Hours STARTED	15	15
Period 2, Second 12 Hours COMPLETED	15	15
Period 2, Second 12 Hours NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=31 Participants Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
Age, Continuous	25.3 years STANDARD_DEVIATION 3.11 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Germany	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Hour 12, each period

Population: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.

The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.

Outcome measures

Outcome measures
Measure	DACP n=31 Participants Nelfilcon A contact lenses	MyDay n=30 Participants Stenfilcon A contact lenses
Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear	22.84 seconds Standard Deviation 3.299	22.87 seconds Standard Deviation 3.026

SECONDARY outcome

Timeframe: Hour 12

Population: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.

The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.

Outcome measures

Outcome measures
Measure	DACP n=31 Participants Nelfilcon A contact lenses	MyDay n=30 Participants Stenfilcon A contact lenses
Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear	0.3 percent distortion per second Standard Deviation 0.38	0.2 percent distortion per second Standard Deviation 0.23

Adverse Events

DACP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MyDay

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

Global Medical Affairs Brand Lead - Vision Care

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