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OpenTrials
Completed

NCT Number: NCT01155726

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

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

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfilcon A contact lens

Device

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®

Nelfilcon A contact lens with comfort additive (DACP), unmasked

Device

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®

Nelfilcon A contact lens with comfort additive (DACP), masked

Device

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®

Nelfilcon A contact lens with comfort additive (DACP), partially masked

Device

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®

Etafilcon A contact lens

Device

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®

Etafilcon A contact lens with comfort additive (1DAVM), unmasked

Device

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®

Etafilcon A contact lens with comfort additive (1DAVM), masked

Device

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®

Etafilcon A contact lens with comfort additive (1DAVM), partially masked

Device

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®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Acronym: ARGON

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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