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Evaluation of Lotrafilcon A Lenses Over a Three Month Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00931307
First received: July 1, 2009
Last updated: June 26, 2012
Last verified: October 2010

July 1, 2009
June 26, 2012
May 2009
September 2009   (final data collection date for primary outcome measure)
Comfort After Insertion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Primary outcome is comfort of lotrafilcon A lenses after insertion, end of day comfort and overall comfort. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00931307 on ClinicalTrials.gov Archive Site
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Evaluation of Lotrafilcon A Lenses Over a Three Month Period
Evaluation of Lotrafilcon A Lenses Over a Three Month Period

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

Not Provided
Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia
Device: Lotrafilcon A contact lens
Silicone hydrogel, spherical, soft contact lens
Experimental: Lotrafilcon A
Intervention: Device: Lotrafilcon A contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00931307
P-335-C-013
Not Provided
Alcon Research ( CIBA VISION )
CIBA VISION
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Not Provided
Alcon Research
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP