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: November 19, 2013
Last verified: November 2013

March 21, 2012
November 19, 2013
May 2012
August 2012   (final data collection date for primary outcome measure)
End-of-day Comfort [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
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.
Complete list of historical versions of study NCT01561560 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Myopia
  • Device: Delefilcon A contact lenses
    CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
    Other Name: DAILIES TOTAL1®
  • Device: Narafilcon A contact lenses
    CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
    Other Name: 1-DAY ACUVUE® TRUEYE™
  • DAILIES TOTAL1, then TRUEYE
    Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
    Interventions:
    • Device: Delefilcon A contact lenses
    • Device: Narafilcon A contact lenses
  • TRUEYE, then DAILIES TOTAL1
    Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
    Interventions:
    • Device: Delefilcon A contact lenses
    • Device: Narafilcon A contact lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sign written Informed Consent Document.
  • Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
  • Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
  • Willing to wear study lenses for at least eight hours per day and at least five days per week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Has 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.
  • Topical ocular or systemic use of antibiotics within seven days of enrollment.
  • Pregnant or nursing women.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01561560
P-347-C-019
No
Alcon Research
Alcon Research
Not Provided
Study Director: Camille Girault Alcon Research
Alcon Research
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP