Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Nelfilcon A contact lens; Device: Narafilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01035905

P-337-C-030

Details and patient eligibility

About

The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Enrollment: 63 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
• Habitually wear lenses for at least 8 hours per day and 4 days per week.
• Report 2 or more qualifying symptoms with current contact lenses.
• Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in any clinical trial.
• Any use of ocular medications, exclusive of contact lens rewetting drops.
• History of corneal or refractive surgery.
• Cylinder correction greater than 1.00 D
• Current monovision contact lens wearers.
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Nelfilcon A

Experimental group

Description:

Nelfilcon A contact lens

Treatment:

Device: Nelfilcon A contact lens

Narafilcon A

Active Comparator group

Description:

Narafilcon A contact lens

Treatment:

Device: Narafilcon A contact lens