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Daily Disposable Toric Comparative Trial in Europe

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ClinicalTrials.gov Identifier: NCT01070381
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : March 24, 2011
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

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

Condition or disease Intervention/treatment Phase
Myopia Astigmatism Device: nelfilcon A contact lens Device: ocufilcon D contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
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.
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
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.
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



Primary Outcome Measures :
  1. Overall Comfort [ Time Frame: 1 week of wear ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01070381     History of Changes
Other Study ID Numbers: P-346-C-008
First Posted: February 18, 2010    Key Record Dates
Results First Posted: March 24, 2011
Last Update Posted: December 13, 2013
Last Verified: January 2012

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases