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
  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:


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
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: 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 August 28, 2014