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

Ciba Vision

Status: Completed

Conditions: Myopia; Hyperopia

Treatments: Device: Etafilcon A contact lens with comfort additive (1DAVM), unmasked; Device: Nelfilcon A contact lens with comfort additive (DACP), partially masked; Device: Nelfilcon A contact lens with comfort additive (DACP), masked; Device: Etafilcon A contact lens with comfort additive (1DAVM), masked; Device: Nelfilcon A contact lens; Device: Nelfilcon A contact lens with comfort additive (DACP), unmasked; Device: Etafilcon A contact lens; Device: Etafilcon A contact lens with comfort additive (1DAVM), partially masked

Study type: Interventional

Funder types: Industry

Identifiers

NCT01155726

P-371-C-101

Details and patient eligibility

About

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

Enrollment: 134 patients

Sex: All

Ages: 17+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 4 patient groups

Nelfilcon A, Masked, Unmasked

Active Comparator group

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.

Treatment:

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

Device: Nelfilcon A contact lens

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

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

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

Nelfilcon A, Masked, Partially Masked

Active Comparator group

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.

Treatment:

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

Device: Nelfilcon A contact lens

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

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

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

Etafilcon A, Masked, Unmasked

Active Comparator group

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.

Treatment:

Device: Etafilcon A contact lens

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

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

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

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

Etafilcon A, Masked, Partially Masked

Active Comparator group

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.

Treatment:

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

Device: Etafilcon A contact lens

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

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

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