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Completed

NCT Number: NCT02103309

Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST® in Japan

The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.

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Key information

Conditions

Refractive Error Astigmatism Eye Diseases Myopia Myopic Astigmatism Refractive Errors

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
  • Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
  • Those who play ball sports at least 1 day per week
  • Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
  • Other protocol-defined inclusion criteria may apply

Exclusion criteria

  • Those who regularly wear the study device
  • Those who require ocular treatment with eye drops
  • Those who have a condition contraindicating soft contact lens wear, such as eye irritation
  • Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
  • Those who are participating in another clinical study or research or have a plan of such participation during the present study
  • Women who are pregnant or intend to become pregnant during the study
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Nelfilcon A contact lenses

Device

Other names: DAILIES® AquaComfort® Plus, DACP

Etafilcon A contact lenses

Device

Other names: 1-DAY ACUVUE® MOIST®

Primary outcomes

  1. Mean Investigator-Rated Lens Centration

    Time frame: After 1 week of wear

    Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.

Secondary outcomes

  1. Mean Investigator-Rated Lens Fit

    Time frame: After 1 week of wear

    Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.

  2. Average Subjective Ratings Score (Lens Handling and Overall Vision)

    Time frame: After 1 week of wear

    The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.

  3. Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)

    Time frame: After 1 week of wear

    The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. "Overall Vision" was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2014
Registry last updated
Oct 29, 2014

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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