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Assessment of Lotrafilcon A Contact Lenses

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ClinicalTrials.gov Identifier: NCT01185834
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : January 24, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of Lotrafilcon A Contact Lenses
Study Start Date : July 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Intervention Details:
    Device: Lotrafilcon A upgrade soft contact lens
    Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.

Outcome Measures

Primary Outcome Measures :
  1. Overall Comfort [ Time Frame: 3 months of wear, replacing lenses monthly ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.


Secondary Outcome Measures :
  1. Overall Lens Fit [ Time Frame: 3 months of wear, replacing lenses monthly ]
    As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Have normal ocular findings.
  • 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.
  • Wear Night & Day contact lenses.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Require concurrent ocular medication.
  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Any active corneal infection.
  • Corneal refractive surgery.
  • Wear AIR OPTIX NIGHT & DAY AQUA lenses.
  • Other protocol-defined exclusion criteria may apply.
More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01185834     History of Changes
Other Study ID Numbers: P-335-C-015
First Posted: August 20, 2010    Key Record Dates
Results First Posted: January 24, 2012
Last Update Posted: July 10, 2012
Last Verified: December 2011