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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

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
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 Name: MyDay®
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 Name: MyDay®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089191


Locations
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Germany
Alcon Investigative Site
Jena, Germany
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Global Medical Affairs, Clinical Manager, Vision Care Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02089191    
Other Study ID Numbers: M-14-006
First Posted: March 17, 2014    Key Record Dates
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015
Last Verified: April 2015
Keywords provided by Alcon Research:
DACP
DAILIES® AquaComfort Plus
Tear film stability
NIK-BUT
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases