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Completed

NCT Number: NCT01561560

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

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

  • Sign written Informed Consent Document.
  • Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
  • Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
  • Willing to wear study lenses for at least eight hours per day and at least five days per week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Has not worn contact lenses before.
  • Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
  • Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
  • Ocular surgery/trauma within the last six months.
  • Topical ocular or systemic use of antibiotics within seven days of enrollment.
  • Pregnant or nursing women.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Other names: DAILIES TOTAL1®

Narafilcon A contact lenses

Device

CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Other names: 1-DAY ACUVUE® TRUEYE™

Primary outcomes

  1. End-of-day Comfort

    Time frame: Week 2

    End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2012
Registry last updated
Jan 7, 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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