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Evaluation of Lotrafilcon A Lenses Over a Three Month Period

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ClinicalTrials.gov Identifier: NCT00931307
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : October 6, 2010
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Brief Summary:
The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.

Condition or disease Intervention/treatment
Myopia Device: Lotrafilcon A contact lens

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Lotrafilcon A Lenses Over a Three Month Period
Study Start Date : May 2009
Primary Completion Date : September 2009
Study Completion Date : September 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 Device: Lotrafilcon A contact lens
Silicone hydrogel, spherical, soft contact lens



Primary Outcome Measures :
  1. Comfort After Insertion [ Time Frame: 3 months ]
    Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's 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 subject 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 inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
  • 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.
  • Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
  • History of corneal refractive surgery.
  • Other protocol inclusion/exclusion criteria may apply.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00931307     History of Changes
Other Study ID Numbers: P-335-C-013
First Posted: July 2, 2009    Key Record Dates
Results First Posted: October 6, 2010
Last Update Posted: June 29, 2012
Last Verified: October 2010