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

• ClinicalTrials.gov Identifier: NCT02089191
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Results First Posted: May 15, 2015
• Last Update Posted: May 15, 2015
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Refractive Error
• Interventions: Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses
• Enrollment: 31

Participant Flow

Recruitment Details	Subjects were recruited from 1 investigational site located in Germany.
Pre-assignment Details

Arm/Group Title	DACP/MyDay	MyDay/DACP
Arm/Group Description	Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2	Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
Period Title: Period 1, First 12 Hours
Started	16	15
Completed	16	15
Not Completed	0	0
Period Title: Period 2, Second 12 Hours
Started	15 [1]	15
Completed	15	15
Not Completed	0	0
[1] One participant discontinued between Period 1 and Period 2 due to availability

Baseline Characteristics

Arm/Group Title		Overall
Arm/Group Description		Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
Overall Number of Baseline Participants		31
Baseline Analysis Population Description		This analysis group includes all enrolled participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	31 participants
		25.3 (3.11)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	31 participants
	Female	22 71.0%
	Male	9 29.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Germany	Number Analyzed	31 participants
		31

Outcome Measures

1. Primary Outcome

Title	Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
Description	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.
Time Frame	Day 1, Hour 12, each period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	DACP	MyDay
Arm/Group Description:	Nelfilcon A contact lenses	Stenfilcon A contact lenses
Overall Number of Participants Analyzed	31	30
Mean (Standard Deviation); Unit of Measure: seconds
	22.84 (3.299)	22.87 (3.026)

2. Secondary Outcome

Title	Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear
Description	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.
Time Frame	Hour 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	DACP	MyDay
Arm/Group Description:	Nelfilcon A contact lenses	Stenfilcon A contact lenses
Overall Number of Participants Analyzed	31	30
Mean (Standard Deviation); Unit of Measure: percent distortion per second
	0.3 (0.38)	0.2 (0.23)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (March 2014 to April 2014). This analysis population includes all participants/eyes exposed to any investigational product evaluated in this study.
Adverse Event Reporting Description	An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users or other persons, whether or not related to the medical device.
Arm/Group Title	DACP	MyDay
Arm/Group Description	Nelfilcon A contact lenses	Stenfilcon A contact lenses
All-Cause Mortality
	DACP	MyDay
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	DACP	MyDay
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/31 (0.00%)	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	DACP	MyDay
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/31 (0.00%)	0/30 (0.00%)

Limitations and Caveats

There was a high censoring rate observed with the objective measurements and therefore there are limitations to the conclusions that may be drawn.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact

• Name/Title: Global Medical Affairs Brand Lead - Vision Care
• Organization: Alcon Research, Ltd.
• Phone: 1-888-451-3937
• EMail: alcon.medinfo@alcon.com

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02089191
• Other Study ID Numbers: M-14-006
• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Results First Submitted: April 30, 2015
• Results First Posted: May 15, 2015
• Last Update Posted: May 15, 2015