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OpenTrials
Completed

NCT Number: NCT02252133

DAILIES TOTAL1® Lens Centration in a Japanese Population

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

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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, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign Informed Consent document.
  • Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
  • Symptoms of contact lens discomfort as defined by protocol.
  • Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
  • Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
  • Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
  • Acceptable contact lens fit with both study contact lenses.
  • Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Currently wearing DT1 or 1DAVTE.
  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
  • Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
  • History of herpetic keratitis, ocular surgery or irregular cornea.
  • Prior refractive surgery (e.g. LASIK, PRK, etc).
  • Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
  • Judged ineligible as a patient in this clinical study by the investigator.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Other names: DAILIES TOTAL1®

Narafilcon A contact lenses

Device

Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Other names: 1-DAY ACUVUE® TruEye®

Primary outcomes

  1. Success Rate of Lens Centration After 7 ± 2 Days of Wear

    Time frame: Day 7, each product

    Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 30, 2014
Registry last updated
Jan 29, 2016

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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