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OpenTrials
Completed

NCT Number: NCT02750813

ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must sign informed consent form;
  • Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
  • Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
  • Cylinder equal or lower than -0.75D in both eyes;
  • Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
  • Can be successfully fitted with both study lenses at Visit 1;
  • Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Fitted with monovision;
  • Prior refractive surgery;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Pregnant or lactating;
  • Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
  • Participation in any clinical study within 30 days of Visit 1;
  • Current DT1 or AO1D lens wearer;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Other names: DAILIES TOTAL1® (DT1)

Senofilcon A contact lenses

Device

Other names: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)

Primary outcomes

  1. Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14

    Time frame: Day 14, each product

    Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

Secondary outcomes

  1. Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14

    Time frame: Day 14, each product

    The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Official study title

ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2016
Registry last updated
Jul 2, 2018

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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