Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: narafilcon A contact lens; Device: nelfilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987623

P-337-C-031

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

Enrollment: 326 patients

Sex: All

Ages: Under 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No previous contact lens experience or attempts to try contact lenses (neophytes).
• Currently wearing spectacles or needing vision correction in both eyes.
• No older than 45 years of age.
• Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
• Interested in wearing contact lenses.
• Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Previous corneal or refractive surgery.
• Currently enrolled in any Clinical Trial.
• 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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326 participants in 2 patient groups

nelfilcon A

Experimental group

Description:

Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.

Treatment:

Device: nelfilcon A contact lens

narafilcon A

Active Comparator group

Description:

Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.

Treatment:

Device: narafilcon A contact lens