Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01035905
First received: December 18, 2009
Last updated: June 26, 2012
Last verified: January 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

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 and reported by the subject in a questionnaire 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 always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.


Enrollment: 63
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 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

  Eligibility

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

Inclusion Criteria:

  • Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
  • Habitually wear lenses for at least 8 hours per day and 4 days per week.
  • Report 2 or more qualifying symptoms with current contact lenses.
  • Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
  • Other protocol-defined 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 ocular medications, exclusive of contact lens rewetting drops.
  • History of corneal or refractive surgery.
  • Cylinder correction greater than 1.00 D
  • Current monovision contact lens wearers.
  • Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01035905     History of Changes
Other Study ID Numbers: P-337-C-030
Study First Received: December 18, 2009
Results First Received: September 27, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014