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Clinical Validation of the New Print on Focus DAILIES Toric

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: NCT01097863
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : June 27, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Tracking Information
First Submitted Date  ICMJE March 31, 2010
First Posted Date  ICMJE April 2, 2010
Results First Submitted Date  ICMJE May 27, 2011
Results First Posted Date  ICMJE June 27, 2011
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. [ Time Frame: 1 week ]
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
The primary efficacy variable(s) of this trial are visibility of the OK inversion indicator on the finger and on the eye and the subject's feeling about the appearance. [ Time Frame: 1 week ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2010)
visual acuity [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Validation of the New Print on Focus DAILIES Toric
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to validate the improvements to the inversion indicator.
Detailed Description This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Device: nelfilcon A contact lens, modified inversion indicator
    Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
  • Device: nelfilcon A contact lens, no inversion indicator
    Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
  • Device: nelfilcon A contact lens, inversion indicator
    Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
    Other Name: Focus DAILIES Toric
Study Arms  ICMJE
  • Experimental: nelfilcon A, modified inversion indicator
    Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
    Intervention: Device: nelfilcon A contact lens, modified inversion indicator
  • Experimental: nelfilcon A, no inversion indicator
    Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
    Intervention: Device: nelfilcon A contact lens, no inversion indicator
  • Active Comparator: nelfilcon A, inversion indicator
    Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
    Intervention: Device: nelfilcon A contact lens, inversion indicator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)
280
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2010)
300
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
  • Willing and able to wear study lenses in both eyes in the available parameters.
  • Light-eyed subjects.
  • Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
  • Optimal or acceptable fit in each eye at time of dispensing.
  • Willing to wear the study lenses at least 8 hours a day, 5 days a week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Eye injury or surgery within twelve weeks prior to enrollment for this trial.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in an ophthalmic clinical trial.
  • Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • RGP contact lens wearer.
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01097863
Other Study ID Numbers  ICMJE P-346-C-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research ( CIBA VISION )
Study Sponsor  ICMJE CIBA VISION
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP