Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01233076
First received: November 1, 2010
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.


Condition Intervention
Myopia
Device: Nelfilcon A contact lens
Device: Narafilcon B contact lens

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Vision Quality [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]
    Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 60
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nelfilcon A / Narafilcon B
Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE TruEye
Narafilcon B / Nelfilcon A
Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
Device: Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
Other Name: DAILIES AquaComfort Plus
Device: Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE TruEye

  Eligibility

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

Inclusion Criteria:

  • Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
  • Able to wear study lenses in the available powers from -1.00D to -6.00D.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury within twelve weeks of enrollment.
  • History of corneal or refractive surgery.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in any clinical trial.
  • Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
  • Monovision correction during the study.
  • 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: NCT01233076     History of Changes
Other Study ID Numbers: P-337-C-034
Study First Received: November 1, 2010
Results First Received: August 5, 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 April 22, 2014