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
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, see Learn About Clinical Studies.

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
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on September 29, 2014