search
Back to results

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

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nelfilcon A contact lens
Nelfilcon A contact lens with comfort additive (DACP), unmasked
Nelfilcon A contact lens with comfort additive (DACP), masked
Nelfilcon A contact lens with comfort additive (DACP), partially masked
Etafilcon A contact lens
Etafilcon A contact lens with comfort additive (1DAVM), unmasked
Etafilcon A contact lens with comfort additive (1DAVM), masked
Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Contact Lens Research: University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Nelfilcon A, Masked, Unmasked

Nelfilcon A, Masked, Partially Masked

Etafilcon A, Masked, Unmasked

Etafilcon A, Masked, Partially Masked

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Average Subjective Comfort
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2010
Last Updated
June 26, 2012
Sponsor
CIBA VISION
search

1. Study Identification

Unique Protocol Identification Number
NCT01155726
Brief Title
The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Acronym
ARGON
Official Title
The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nelfilcon A, Masked, Unmasked
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nelfilcon A, Masked, Partially Masked
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Etafilcon A, Masked, Unmasked
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Etafilcon A, Masked, Partially Masked
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lens
Other Intervention Name(s)
Focus DAILIES®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lens with comfort additive (DACP), unmasked
Other Intervention Name(s)
DAILIES® AquaComfort Plus®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lens with comfort additive (DACP), masked
Other Intervention Name(s)
DAILIES® AquaComfort Plus®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lens with comfort additive (DACP), partially masked
Other Intervention Name(s)
DAILIES® AquaComfort Plus®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Etafilcon A contact lens
Other Intervention Name(s)
1-DAY ACUVUE®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Etafilcon A contact lens with comfort additive (1DAVM), unmasked
Other Intervention Name(s)
1-DAY ACUVUE® MOIST®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Etafilcon A contact lens with comfort additive (1DAVM), masked
Other Intervention Name(s)
1-DAY ACUVUE® MOIST®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Etafilcon A contact lens with comfort additive (1DAVM), partially masked
Other Intervention Name(s)
1-DAY ACUVUE® MOIST®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Subjective Comfort
Description
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.
Time Frame
Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre for Contact Lens Research: University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs