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Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958828
First Posted: August 13, 2009
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  Purpose
The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • Overall Lens Satisfaction [ Time Frame: After 1 week of wear ]
    Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 178
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
Nelfilcon A / Narafilcon A
Nelfilcon A contact lenses, then Narafilcon A contact lenses
Device: Nelfilcon A contact lens
Spherical, soft contact lens for daily disposable wear
Device: Narafilcon A contact lens
Spherical, soft contact lens for daily disposable wear
Narafilcon A / Nelfilcon A
Narafilcon A contact lenses, then Nelfilcon A contact lenses
Device: Nelfilcon A contact lens
Spherical, soft contact lens for daily disposable wear
Device: Narafilcon A contact lens
Spherical, soft contact lens for daily disposable wear

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment.
  • Currently wearing contact lenses at least 8 hours/day and 5 days/week.
  • 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.
  • Prior history of corneal or refractive surgery.
  • Monovision correction.
  • Other protocol inclusion/exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00958828     History of Changes
Other Study ID Numbers: P-337-C-028
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: September 23, 2010
Results First Posted: October 19, 2010
Last Update Posted: July 10, 2012
Last Verified: January 2012