Daily Disposable Toric Comparative Trial in Europe

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01070381
First received: February 16, 2010
Last updated: November 19, 2013
Last verified: January 2012

February 16, 2010
November 19, 2013
January 2010
March 2010   (final data collection date for primary outcome measure)
Overall Comfort [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]
Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.
lens fit [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070381 on ClinicalTrials.gov Archive Site
Not Provided
visual acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Daily Disposable Toric Comparative Trial in Europe
Not Provided

The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myopia
  • Astigmatism
  • Device: nelfilcon A contact lens
    Commercially marketed, toric, soft contact lens for daily disposable wear
  • Device: ocufilcon D contact lens
    Commercially marketed, toric, soft contact lens for daily disposable wear
  • nelfilcon A / ocufilcon D
    Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
    Interventions:
    • Device: nelfilcon A contact lens
    • Device: ocufilcon D contact lens
  • ocufilcon D / nelfilcon A
    Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
    Interventions:
    • Device: nelfilcon A contact lens
    • Device: ocufilcon D contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
  • Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
  • Achieve acceptable or optimal fit in each eye at time of dispense.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Habitual daily disposable contact lens wearer.
  • Sleeps in contact lenses overnight.
  • Currently enrolled in an ophthalmic clinical trial.
  • Other protocol-defined exclusion criteria may apply.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01070381
P-346-C-008
Not Provided
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
January 2012

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