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Assessment of Lotrafilcon A Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01185834
First received: August 18, 2010
Last updated: June 26, 2012
Last verified: December 2011
History of Changes
  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 Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessment of Lotrafilcon A Contact Lenses

Resource links provided by NLM:

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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Comfort [ Time Frame: 3 months of wear, replacing lenses monthly ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01185834     History of Changes
Other Study ID Numbers: P-335-C-015
Study First Received: August 18, 2010
Results First Received: December 20, 2011
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 21, 2013