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Clinical Validation of the New Print on Focus DAILIES Toric

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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 )

March 31, 2010
April 2, 2010
May 27, 2011
June 27, 2011
July 10, 2012
March 2010
May 2010   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01097863 on ClinicalTrials.gov Archive Site
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visual acuity [ Time Frame: 1 week ]
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Clinical Validation of the New Print on Focus DAILIES Toric
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The purpose of this study is to validate the improvements to the inversion indicator.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myopia
  • 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
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
300
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01097863
P-346-C-010
No
Not Provided
Not Provided
Alcon Research ( CIBA VISION )
CIBA VISION
Not Provided
Not Provided
Alcon Research
January 2012

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