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Assessment of Lotrafilcon A Contact Lenses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185834
First Posted: August 20, 2010
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  Purpose
The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Condition Intervention
Myopia Device: Lotrafilcon A upgrade soft contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of Lotrafilcon A Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 118
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01185834     History of Changes
Other Study ID Numbers: P-335-C-015
First Submitted: August 18, 2010
First Posted: August 20, 2010
Results First Submitted: December 20, 2011
Results First Posted: January 24, 2012
Last Update Posted: July 10, 2012
Last Verified: December 2011