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
  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:


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
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, see Learn About Clinical Studies.

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 August 01, 2014