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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02089191
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 30.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: DACP/MyDay Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.	Device: Nelfilcon A contact lenses; Other Names: DAILIES® AquaComfort Plus® DACP ; Device: Stenfilcon A contact lenses; Other Names: MyDay®
Other: MyDay/DACP Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day.	Device: Nelfilcon A contact lenses; Other Names: DAILIES® AquaComfort Plus® DACP ; Device: Stenfilcon A contact lenses; Other Names: MyDay®

Outcome Measures

Primary Outcome Measures

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

   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.

Secondary Outcome Measures

1. Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear [Hour 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must sign an Informed Consent form;

• Adapted, current soft contact lens wearer;

• Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));

• Cylinder ≤ -1.00 D in both eyes at Visit 1;

• Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;

• Willing to wear study lenses up to 12 hours and attend all study visits;

• Able to be successfully fitted with study lenses;

• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;

• Use of artificial tears and rewetting drops during the study;

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• Any abnormal ocular condition observed during Visit 1;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Pregnant or lactating;

• Participation in any clinical study within 30 days of Visit 1;

• Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Jena		Germany

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Global Medical Affairs, Clinical Manager, Vision Care, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02089191
• Other Study ID Numbers: M-14-006
• First Posted: Mar 17, 2014
• Last Update Posted: May 15, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Alcon Research: DACP; DAILIES® AquaComfort Plus; Tear film stability; NIK-BUT
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

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

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 1, First 12 Hours
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

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 Participants	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (3.11)
Sex: Female, Male (Count of Participants)
Female	22 71%
Male	9 29%
Region of Enrollment (participants) [Number]
Germany	31 100%

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
Measure Participants	31	30
Mean (Standard Deviation) [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
Measure Participants	31	30
Mean (Standard Deviation) [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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	DACP		MyDay
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	DACP		MyDay
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)

Limitations/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.

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