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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
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: 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

ClinicalTrials.gov processed this record on November 20, 2014