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

Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Nelfilcon A contact lenses; Device: Stenfilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany
    • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: DACP; DAILIES® AquaComfort Plus; Tear film stability; NIK-BUT
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: M-14-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No