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Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT00987623
First received: September 29, 2009
Last updated: June 26, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).


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: Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Lens Satisfaction [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Overall Lens Satisfaction, as interpreted by the participant and reported 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: 326
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nelfilcon A
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
 Device: nelfilcon A contact lens
Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
Active Comparator: narafilcon A
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
 Device: narafilcon A contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No previous contact lens experience or attempts to try contact lenses (neophytes).
  • Currently wearing spectacles or needing vision correction in both eyes.
  • No older than 45 years of age.
  • Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
  • Interested in wearing contact lenses.
  • Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Previous corneal or refractive surgery.
  • Currently enrolled in any Clinical Trial.
  • Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987623

Locations
United States, Pennsylvania
The Research Intelligence Group (TRiG)
Fort Washington, Pennsylvania, United States, 19034
Sponsors and Collaborators
CIBA VISION
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00987623     History of Changes
Other Study ID Numbers: P-337-C-031
Study First Received: September 29, 2009
Results First Received: December 17, 2010
Last Updated: June 26, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013