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OpenTrials
Completed

NCT Number: NCT02089191

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

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.

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Key information

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site

Jena, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfilcon A contact lenses

Device

Other names: DAILIES® AquaComfort Plus®, DACP

Stenfilcon A contact lenses

Device

Other names: MyDay®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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