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Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00813982
First received: December 22, 2008
Last updated: June 26, 2012
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.


Condition Intervention
Myopia
 Device: Lotrafilcon A Experimental Contact Lens
Device: Lotrafilcon A Commercial Contact Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel 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 Vision [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 60
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Lotrafilcon A Contact Lens
Lotrafilcon A experimental contact lens randomly assigned to one eye
 Device: Lotrafilcon A Experimental Contact Lens
Experimental spherical, silicone hydrogel soft contact lens
Active Comparator: Commercial Lotrafilcon A Contact Lens
Lotrafilcon A commercial contact lens randomly assigned to one eye
 Device: Lotrafilcon A Commercial Contact Lens
Commercially marketed spherical, silicone hydrogel soft contact lens

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
  • On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Requires concurrent ocular medication
  • Eye injury or surgery within twelve weeks immediately prior to enrollment
  • Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
  • Any active corneal infection
  • Any use of medications for which contact lens wear would be contraindicated
  • History of corneal refractive surgery
  • Wears toric contact lenses
  • Other protocol-defined inclusion/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: NCT00813982     History of Changes
Other Study ID Numbers: P-335-C-009
Study First Received: December 22, 2008
Results First Received: September 3, 2010
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