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

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

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

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nelfilcon A, Masked, Unmasked<br>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<br>* 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.<br>* Other names: Focus DAILIES®;Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Nelfilcon A contact lens with comfort additive (DACP), masked<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;Device: Etafilcon A contact lens with comfort additive (1DAVM), masked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;|
| Active Comparator: Nelfilcon A, Masked, Partially Masked<br>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<br>* 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.<br>* Other names: Focus DAILIES®;Device: Nelfilcon A contact lens with comfort additive (DACP), masked<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Etafilcon A contact lens with comfort additive (1DAVM), masked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;|
| Active Comparator: Etafilcon A, Masked, Unmasked<br>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<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Nelfilcon A contact lens with comfort additive (DACP), masked<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Etafilcon A contact lens<br>* 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.<br>* Other names: 1-DAY ACUVUE®;Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;Device: Etafilcon A contact lens with comfort additive (1DAVM), masked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;|
| Active Comparator: Etafilcon A, Masked, Partially Masked<br>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<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked<br>* 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.<br>* Other names: DAILIES® AquaComfort Plus®;Device: Etafilcon A contact lens<br>* 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.<br>* Other names: 1-DAY ACUVUE®;Device: Etafilcon A contact lens with comfort additive (1DAVM), masked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked<br>* 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.<br>* Other names: 1-DAY ACUVUE® MOIST®;|

What is the study measuring?
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Primary Outcome Measures

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