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

  Purpose

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

Condition

Intervention

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

• Average Subjective Comfort [ Time Frame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3 ] [ Designated as safety issue: No ]
  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.
  
  

Enrollment:	134
Study Start Date:	May 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155726

Locations

Canada, Ontario

Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

CIBA VISION

  More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01155726     History of Changes
Other Study ID Numbers:	P-371-C-101
Study First Received:	June 30, 2010
Results First Received:	February 15, 2012
Last Updated:	June 26, 2012
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Hyperopia Myopia Refractive Errors Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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