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The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies (ARGON)

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ClinicalTrials.gov Identifier: NCT01155726
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : May 15, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Tracking Information
First Submitted Date  ICMJE June 30, 2010
First Posted Date  ICMJE July 2, 2010
Results First Submitted Date  ICMJE February 15, 2012
Results First Posted Date  ICMJE May 15, 2012
Last Update Posted Date July 10, 2012
Study Start Date  ICMJE May 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2012)		 Average Subjective Comfort [ Time Frame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3 ]
Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2010)		 The primary outcome is subjective comfort. [ Time Frame: 60 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Official Title  ICMJE The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Brief Summary The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Myopia
  • Hyperopia
Intervention  ICMJE
  • Device: Nelfilcon A contact lens
    Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
    Other Name: Focus DAILIES®
  • Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked
    Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
    Other Name: DAILIES® AquaComfort Plus®
  • Device: Nelfilcon A contact lens with comfort additive (DACP), masked
    Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
    Other Name: DAILIES® AquaComfort Plus®
  • Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked
    Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
    Other Name: DAILIES® AquaComfort Plus®
  • Device: Etafilcon A contact lens
    Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
    Other Name: 1-DAY ACUVUE®
  • Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked
    Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
    Other Name: 1-DAY ACUVUE® MOIST®
  • Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
    Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
    Other Name: 1-DAY ACUVUE® MOIST®
  • Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
    Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
    Other Name: 1-DAY ACUVUE® MOIST®
Study Arms  ICMJE
  • Active Comparator: Nelfilcon A, Masked, Unmasked
    Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
    Interventions:
    • Device: Nelfilcon A contact lens
    • Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked
    • Device: Nelfilcon A contact lens with comfort additive (DACP), masked
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
  • Active Comparator: Nelfilcon A, Masked, Partially Masked
    Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
    Interventions:
    • Device: Nelfilcon A contact lens
    • Device: Nelfilcon A contact lens with comfort additive (DACP), masked
    • Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
  • Active Comparator: Etafilcon A, Masked, Unmasked
    Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
    Interventions:
    • Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked
    • Device: Nelfilcon A contact lens with comfort additive (DACP), masked
    • Device: Etafilcon A contact lens
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
  • Active Comparator: Etafilcon A, Masked, Partially Masked
    Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.
    Interventions:
    • Device: Nelfilcon A contact lens with comfort additive (DACP), masked
    • Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked
    • Device: Etafilcon A contact lens
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), masked
    • Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked
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: April 18, 2012)		 134
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2010)		 100
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 17 years of age or older.
  • Ocular exam within 2 years.
  • Currently wearing soft contact lenses on a daily wear basis.
  • Contact lens prescription between +6.00D and -10.00D.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular disease.
  • Use of systemic or ocular medications that may affect ocular health.
  • Unable to achieve an acceptable fit with the study lenses.
  • Anisometropia >1.00D or astigmatism >0.75D.
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01155726
Other Study ID Numbers  ICMJE P-371-C-101
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 April 2012

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