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OpenTrials
Completed

NCT Number: NCT02710292

Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Japan, Ltd. for Trial Locations

Tokyo, 107-0052, Japan

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;
  • Habitual current daily disposable soft contact lenses wearer;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
  • Lenses within the power range specified in the protocol;
  • Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
  • Acceptable lens fit with both study contact lenses;
  • Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Currently wearing DT1 or TE sphere lenses;
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
  • Eye injury or surgery within 12 weeks immediately prior to enrollment;
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Prior refractive surgery;
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens;
  • Participation in any clinical trial within 30 days of the enrollment visit;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Other names: DAILIES TOTAL 1®, DT1

Narafilcon A contact lenses

Device

Other names: 1-DAY ACUVUE® TruEye®

Primary outcomes

  1. Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear

    Time frame: Day 10, each product

    Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 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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