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
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: 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
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014