Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01207466
First received: September 21, 2010
Last updated: June 27, 2012
Last verified: January 2012
  Purpose

The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.


Condition Intervention
Astigmatism
Myopia
Device: Nelfilcon A investigational contact lens
Device: Nelfilcon A commercial contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Quality of Vision (Crisp and Clear) [ Time Frame: 1 week of wear ] [ Designated as safety issue: No ]
    Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week's wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.


Enrollment: 95
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nelfilcon A invest'l / nelfilconA comm'l
Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
Device: Nelfilcon A investigational contact lens
Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
Device: Nelfilcon A commercial contact lens
Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
Other Name: Focus DAILIES Toric
Nelfilcon A comm'l / nelfilconA invest'l
Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
Device: Nelfilcon A investigational contact lens
Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
Device: Nelfilcon A commercial contact lens
Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
Other Name: Focus DAILIES Toric

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently wearing soft contact lenses with astigmatism correction
  • Other protocol inclusion criteria may apply

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment
  • Currently enrolled in an ophthalmic clinical trial
  • Strabismus
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
  • Other protocol 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: NCT01207466     History of Changes
Other Study ID Numbers: P-415-C-001 sub 2
Study First Received: September 21, 2010
Results First Received: July 28, 2011
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014