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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01561560
First received: March 21, 2012
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this post-market, multi-center, multi-national study is to evaluate the end-of-day comfort of two contact lenses.


Condition Intervention
Myopia
 Device: delefilcon A contact lens (DAILIES TOTAL1®)
Device: narafilcon A contact lens (1-DAY ACUVUE® TRUEYE™)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

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:
  • End-of-day Comfort [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    As interpreted and reported by the subject on a questionnaire as a single, retrospective measurement of 2 weeks of wear time. End-of-day comfort will be rated on a continuous 1 to 10 Likert scale where 1=poor and 10=excellent.


Estimated Enrollment: 120
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
delefilcon A, then narafilcon A
Delefilcon A contact lenses worn first, with narafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for two weeks each.
 Device: delefilcon A contact lens (DAILIES TOTAL1®)
CE-marked, silicone hydrogel, soft contact lens for daily wear, daily disposable use, to be worn bilaterally for 14 days in either Period One or Period Two.
Other Name: (DAILIES TOTAL1®)
Device: narafilcon A contact lens (1-DAY ACUVUE® TRUEYE™)
CE-marked, silicone hydrogel, soft contact lens for daily wear, daily disposable use, to be worn bilaterally for 14 days in either Period One or Period Two.
Other Name: (1-DAY ACUVUE® TRUEYE™)
narafilcon A, then delefilcon A
Narafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for two weeks each.
 Device: delefilcon A contact lens (DAILIES TOTAL1®)
CE-marked, silicone hydrogel, soft contact lens for daily wear, daily disposable use, to be worn bilaterally for 14 days in either Period One or Period Two.
Other Name: (DAILIES TOTAL1®)
Device: narafilcon A contact lens (1-DAY ACUVUE® TRUEYE™)
CE-marked, silicone hydrogel, soft contact lens for daily wear, daily disposable use, to be worn bilaterally for 14 days in either Period One or Period Two.
Other Name: (1-DAY ACUVUE® TRUEYE™)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Currently wearing soft contact lenses in both eyes.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Neophytes (i.e., not worn contact lenses before).
  • Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
  • Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
  • Ocular surgery/trauma within the last six months.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561560

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Director, Global Medical Affairs Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01561560     History of Changes
Other Study ID Numbers: P-347-C-019
Study First Received: March 21, 2012
Last Updated: September 20, 2012
Health Authority: United Kingdom: Research Ethics Committee
Finland: Ethics Committee
Germany: Ethics Commission

Keywords provided by Alcon Research:
DAILIES TOTAL1
contact lenses
myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013