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
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


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

Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01070381     History of Changes
Other Study ID Numbers: P-346-C-008
Study First Received: February 16, 2010
Results First Received: February 25, 2011
Last Updated: November 19, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 14, 2014