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Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987623
First Posted: October 1, 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 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: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall Lens Satisfaction [ Time Frame: 1 week ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987623


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

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT00987623     History of Changes
Other Study ID Numbers: P-337-C-031
First Submitted: September 29, 2009
First Posted: October 1, 2009
Results First Submitted: December 17, 2010
Results First Posted: January 13, 2011
Last Update Posted: July 10, 2012
Last Verified: January 2012