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OpenTrials
Completed

NCT Number: NCT00987623

Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

Up to 45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Research Intelligence Group (TRiG)

Fort Washington, Pennsylvania, 19034, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • No previous contact lens experience or attempts to try contact lenses (neophytes).
  • Currently wearing spectacles or needing vision correction in both eyes.
  • No older than 45 years of age.
  • Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
  • Interested in wearing contact lenses.
  • Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Previous corneal or refractive surgery.
  • Currently enrolled in any Clinical Trial.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Nelfilcon A contact lens

Device

Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.

Narafilcon A contact lens

Device

Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.

Primary outcomes

  1. Overall Lens Satisfaction

    Time frame: 1 week

    Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 1, 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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