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Daily Disposable Toric Comparative Trial in Europe

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070381
First Posted: February 18, 2010
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
  Purpose
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Condition Intervention
Myopia Astigmatism Device: nelfilcon A contact lens Device: ocufilcon D contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research ( CIBA VISION ):

Primary Outcome Measures:
  • 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.


Enrollment: 220
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01070381     History of Changes
Other Study ID Numbers: P-346-C-008
First Submitted: February 16, 2010
First Posted: February 18, 2010
Results First Submitted: February 25, 2011
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