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

June 26, 2012 updated by: CIBA VISION
The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research: University of Waterloo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 1-DAY ACUVUE® MOIST®
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 Names:
  • DAILIES® AquaComfort Plus®
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 1-DAY ACUVUE® MOIST®
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 Names:
  • 1-DAY ACUVUE®
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 Names:
  • 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 Names:
  • 1-DAY ACUVUE® MOIST®
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 Names:
  • DAILIES® AquaComfort Plus®
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 Names:
  • 1-DAY ACUVUE® MOIST®
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 Names:
  • 1-DAY ACUVUE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CIBA VISION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-371-C-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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