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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
  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:


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
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.

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

ClinicalTrials.gov processed this record on November 20, 2014