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

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ClinicalTrials.gov Identifier: NCT00933166
Recruitment Status : Completed
First Posted : July 7, 2009
Results First Posted : December 23, 2010
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

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

Condition or disease Intervention/treatment Phase
Myopia Device: Lotrafilcon A contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
Study Start Date : June 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lotrafilcon A
Investigational contact lens worn in both eyes for three months
Device: Lotrafilcon A contact lens
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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00933166     History of Changes
Other Study ID Numbers: P-335-C-014v2
First Posted: July 7, 2009    Key Record Dates
Results First Posted: December 23, 2010
Last Update Posted: July 10, 2012
Last Verified: January 2012