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

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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:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE March 14, 2014
First Posted Date  ICMJE March 17, 2014
Results First Submitted Date  ICMJE April 30, 2015
Results First Posted Date  ICMJE May 15, 2015
Last Update Posted Date May 15, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
Time to 15% Distortion After 12 Hours [ Time Frame: Hour 12 ]
Time from first eye opening to 15% distortion of the ring mires projected onto the tear film. The right eye will be used for the analysis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
Speed of Tear Film Break Up at 15 Seconds After 12 Hours [ Time Frame: Hour 12 ]
The slope of the regression line (distorted areas vs. time) will be calculated. The right eye will be used for the analysis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses
Official Title  ICMJE Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Refractive Error
Intervention  ICMJE
  • Device: Nelfilcon A contact lenses
    Other Names:
    • DAILIES® AquaComfort Plus®
    • DACP
  • Device: Stenfilcon A contact lenses
    Other Name: MyDay®
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Nelfilcon A contact lenses
    • Device: Stenfilcon A contact lenses
  • 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.
    Interventions:
    • Device: Nelfilcon A contact lenses
    • Device: Stenfilcon A contact lenses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2014)
31
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02089191
Other Study ID Numbers  ICMJE M-14-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Medical Affairs, Clinical Manager, Vision Care Alcon Research
PRS Account Alcon Research
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP