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
  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:


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
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: 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 July 22, 2014