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Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01494545
First received: December 15, 2011
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.


Condition Intervention
Myopia
 Device: Delefilcon A contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

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:
  • Comfort Upon Insertion [ Time Frame: Two weeks, replacing lenses daily ] [ Designated as safety issue: No ]
    As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 2 weeks of wear time. Comfort upon insertion will be evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 102
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delefilcon A
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. Subject will insert a new pair each day and discard it at the end of the day.
 Device: Delefilcon A contact lens
Silicone hydrogel, spherical contact lens CE-marked for single use, daily disposable wear
Other Name: DAILIES® TOTAL1™

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be of legal age of consent.
  • Have no previous contact lens experience and have not attempted to try contact lenses (neophyte).
  • Be willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
  • Use spectacle lenses for vision correction per protocol-specified power range.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Be 45 years or older
  • Prior wear experience with rigid or soft contact lenses. Subjects who attended a contact lens fitting evaluation in the past without lens dispense may participate in study.
  • Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
  • History of ocular surgery/trauma within the last six months.
  • Pregnant or nursing women.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494545

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01494545     History of Changes
Other Study ID Numbers: P-347-C-016
Study First Received: December 15, 2011
Last Updated: June 4, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Alcon Research:
DAILIES TOTAL1
Alcon
contact lens

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013