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OpenTrials
Completed

NCT Number: NCT01362894

Clinical Comparison of Two Daily Disposable Toric Lenses

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign written informed consent.
  • Germany: Be of legal age.
  • Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Wears contact lenses overnight while sleeping.
  • Habitual daily disposable contact lens wearer.
  • Monovision correction during the study.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Nelfilcon A contact lens

Device

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.

Other names: Focus® DAILIES® Toric

Etafilcon A contact lens

Device

Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.

Other names: 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM

Primary outcomes

  1. Overall Vision

    Time frame: 1 week, replacing lenses daily

    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

  2. Overall Comfort

    Time frame: 1 week, replacing lenses daily

    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.

  3. Overall Handling

    Time frame: 1 week, replacing lenses daily

    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.

  4. Overall Satisfaction

    Time frame: 1 week, replacing lenses daily

    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.

Secondary outcomes

  1. Ease of Selecting Final Lens Power

    Time frame: Day 0

    As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 1, 2011
Registry last updated
Aug 9, 2012

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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