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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00958828
First received: August 11, 2009
Last updated: June 26, 2012
Last verified: January 2012
  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 Blind (Subject)
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:

Primary Outcome Measures:
  • Overall Lens Satisfaction [ Time Frame: After 1 week of wear ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
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: NCT00958828     History of Changes
Other Study ID Numbers: P-337-C-028
Study First Received: August 11, 2009
Results First Received: September 23, 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 21, 2014