ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

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.
ClinicalTrials.gov Identifier: NCT01207466
Recruitment Status : Completed
First Posted : September 23, 2010
Results First Posted : August 26, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

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

Condition or disease Intervention/treatment Phase
Astigmatism Myopia Device: Nelfilcon A investigational contact lens Device: Nelfilcon A commercial contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Quality of Vision (Crisp and Clear) [ Time Frame: 1 week of wear ]
    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.



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:

  • 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

Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01207466     History of Changes
Other Study ID Numbers: P-415-C-001 sub 2
First Posted: September 23, 2010    Key Record Dates
Results First Posted: August 26, 2011
Last Update Posted: July 10, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases