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OpenTrials
Completed

NCT Number: NCT01035905

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

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

  • Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
  • Habitually wear lenses for at least 8 hours per day and 4 days per week.
  • Report 2 or more qualifying symptoms with current contact lenses.
  • Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in any clinical trial.
  • Any use of ocular medications, exclusive of contact lens rewetting drops.
  • History of corneal or refractive surgery.
  • Cylinder correction greater than 1.00 D
  • Current monovision contact lens wearers.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Nelfilcon A contact lens

Device

Daily disposable contact lens worn in a daily wear, daily disposable mode

Narafilcon A contact lens

Device

Daily disposable contact lens worn in a daily wear, daily disposable mode

Primary outcomes

  1. Lens Awareness

    Time frame: 4 weeks of wear

    Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 21, 2009
Registry last updated
Jul 10, 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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