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OpenTrials
Completed

NCT Number: NCT00933166

Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

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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

  • On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
  • Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
  • Be able to wear the study lenses in the available powers.
  • Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
  • History of corneal refractive surgery.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Lotrafilcon A contact lens

Device

Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

Primary outcomes

  1. Comfort After Insertion

    Time frame: 3 months

    Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion 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
Jul 7, 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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