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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 )

July 2, 2009
July 7, 2009
December 2, 2010
December 23, 2010
July 10, 2012
June 2009
November 2009   (Final data collection date for primary outcome measure)
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.
Primary efficacy variables are ratings for comfort after insertion, end of day comfort, overall comfort and agreements. [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00933166 on ClinicalTrials.gov Archive Site
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Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myopia
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
Experimental: Lotrafilcon A
Investigational contact lens worn in both eyes for three months
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
169
200
November 2009
November 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 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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00933166
P-335-C-014v2
No
Not Provided
Not Provided
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
January 2012

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