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

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: 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 )

Study Description
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Brief Summary:
The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia 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: Nelfilcon A contact lens with comfort additive (DACP), partially 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 Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arms and Interventions
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Arm Intervention/treatment
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.
 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: 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®
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.
 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), 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 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®
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.
 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: 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®
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.
 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), 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®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155726


Locations
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Canada, Ontario
Centre for Contact Lens Research: University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
More Information
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Responsible Party: CIBA VISION
ClinicalTrials.gov Identifier: NCT01155726    
Other Study ID Numbers: P-371-C-101
First Posted: July 2, 2010    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: July 10, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperopia
Refractive Errors
Eye Diseases