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Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00953407
First received: July 8, 2009
Last updated: June 26, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.


Condition Intervention
Myopia
 Device: Nelfilcon A contact lens
Device: Narafilcon A contact lens
Device: Etafilcon A contact lens
Device: Omafilcon A contact lens
Device: Hilafilcon B contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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:
  • Lens Awareness [ Time Frame: 4 weeks of wear ] [ Designated as safety issue: No ]
    Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.


Enrollment: 128
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nelfilcon A
Nelfilcon A contact lens
 Device: Nelfilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Narafilcon A
Narafilcon A contact lens
 Device: Narafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Etafilcon A
Etafilcon A contact lens
 Device: Etafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Omafilcon A
Omafilcon A contact lens
 Device: Omafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Hilafilcon B
Hilafilcon B contact lens
 Device: Hilafilcon B contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode

  Eligibility

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

Inclusion Criteria:

  • Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
  • Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
  • Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
  • Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
  • Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in any clinical trial.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • History of corneal refractive surgery.
  • Cylinder correction greater than 1.00 D.
  • Current monovision contact lens wearers.
  • Other protocol 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: NCT00953407     History of Changes
Other Study ID Numbers: P-337-C-027
Study First Received: July 8, 2009
Results First Received: September 16, 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 16, 2013